Clinical Trials
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Central Nervous System
Risk of Falls in Fibromyalgia (FM)
Mar 2013Fibromyalgia is a chronic illness characterized by persistent widespread muscle pain with generalised hyperalgesia and allodynia. It can be accompanied by other concomitant symptoms: fatigue, sleep disturbances, musculoskeletal disorders, distress and psychological disorders. The prevalence has been reported to be between 2 and 5%. The hypothesis of this study is that women with fibromyalgia present high risk of falls and balance disorders compared with healthy women. The objective of this study was to investigate wether gait pattern changes in single and dual task conditions were associated with the risk of falling in women with fibromyalgia.
Neurodynamic Intervention in Fibromyalgia (FM)
Mar 2013Fibromyalgia is a chronic illness characterised by persistent,widespread muscle pain with generalised hyperalgesia and allodynia. It can be accompanied by other concomitant symptoms like fatigue, sleep disturbances, musculoskeletal disorders, distress and psychological disorders. This condition is very prevalent. It has been reported to be about 2-5% of the general global population. Fibromyalgia have been reported to have neurodynamic disorders. The purpose of this prospective study was to examine the combined effects of soft tissue mobilization and nerve slider neurodynamic technique on pain and pressure sensitivity in women with fibromyalgia.
Cognitive Remediation in ADHD Children : Comparison Between Three Therapeutic Strategies : Cognitive Remediation With a Virtual Classroom Software and Methylphenidate and Supportive Psychotherapy (RECOGNITA)
Mar 2013The Attention Deficit Disorder with or without Hyperactivity (ADHD) is one of the most frequently found disorder in children. It is characterized by a triad of symptoms involving attention deficit, hyperactivity and impulsivity and having an impact on the functioning of the subject especially in terms of learning. Currently, main interventions to treat ADHD in children are stimulant medication or supportive psychotherapy. Data from recent studies highlight the use of stimulant drugs (amphetamine derivatives such as methylphenidate) to treat the core symptoms of ADHD children. These drugs are generally effective but their nature (psychostimulants) and adverse effects they cause (appetite suppression, sleep disturbances, headaches, motor tics, abdominal pain, irritability, nausea and fatigue) encourage the development of new therapeutic approaches. The use of supportive psychotherapy alone would have limited effect on symptoms of children with ADHD. Our aim is to test the use a cognitive remediation program using a virtual classroom in children suffering from ADHD.
Sensory Support Care for Elderly Patients Suffering From Alzheimer'S-type Neurodegenerative Disease (SensiCare)
Mar 2013The main objective of this study is to evaluate the effect of 3 months of "Snoezelen-type" multi-sensory care sessions on NeuroPsychiatric Inventory Questionnaire (NPI-Q) scores for patients with Alzheimer's-type neurodegenerative disease.
Cortical Excitability Changes Induced by Retigabine: a Transcranial Magnetic Stimulation Study (CERETI)
Mar 2013The objective of this study is to characterize the effects of a single-dose of retigabine on cortical excitability in healthy subjects, as quantified by means of TMS.
Obstructive Sleep Apneas in Elderly:Neuroimaging Changes and Neurocognitive Function Before and After Treatment
Mar 2013In the near future more than 20% of the European population will be over 65 years old and the prevalence of obstructive sleep apnea (OSA) in this aged population is known to be higher than 50%. OSA is a risk factor for cognitive dysfunction in middle-aged subjects, but the relationship between cognitive impairment and sleep breathing disorders (SBD) in the elderly has scarcely been observed. The aim of this study is to investigate cognitive performance in elderly OSA patients, the corresponding brain morphology changes and biological markers and their reversibility with continuous positive airway pressure (CPAP) treatment.
Cognitive Behavioral Therapy Treatment of Depression With Smartphone Support
Mar 2013The purpose of this study is to investigate whether face-to-face Cognitive Behavioral Therapy (CBT) with a smartphone application, focused on providing support in homework assignments and an increase in behavioral activation, is effective in treating mild to moderate depression. The study will be conducted as a randomized controlled treatment study investigating the effect of the current blended treatment compared to treatment as usual.
Effect of Rotigotine Patch Treatment on Cardiovascular Markers in Idiopathic Restless Legs Syndrome
Mar 2013The main aim of this study was to evaluate the impact of rotigotine patch treatment on validated cardiovascular risk factors ambulatory BP during night, day and night-to-day ratio, and endothelial function in patients with idiopathic RLS compared to placebo.
Executive Dysfunction in Restless Legs Syndrome: Clinical Correlates and Outcome After Therapeutic Management
Mar 2013Restless leg syndrome (RLS) is a common neurological disorder whose diagnosis is only clinical. The efficacy of dopaminergic agents in improvement of sensorimotor symptoms advance the hypothesis that altered dopaminergic transmission is at the origin of this condition. RLS usually leads to a sleep fragmentation, which induces sometimes severe insomnia most often associated, in clinical practice, to a cognitive complaint (attentional in nature). Executive functions in which dopaminergic transmission is heavily involved refer to a set of complex functions. At least three of them should be considered during their evaluation (ie flexibility, inhibition, and the updating of working memory). These functions are among the targets of the alteration of the quality and quantity of sleep. The few studies that have focused on the study of the integrity of executive functions in RLS have discordant results. The lack of control of key variables in the assessment of executive functioning (ie intellectual performance, depressive symptomatology, generalized slowing in information processing) and the lack of reference in the theoretical approach in executive functions are certainly the two main reasons. Moreover, the question of polysomnographic correlates and the reversibility of these cognitive abnormalities after pharmacological management of RLS remains unanswered today. The main objective of this study is to compare the executive performance of untreated RLS patients with a group of matched controls.
Role of Dopamine on Loss Aversion Behaviour: Study on Parkinsonian Patients
Mar 2013Many decisions involve the possibility of gaining or losing relative to the status quo. The loss aversion behaviour is a cognitive concept explaining that people are more sensitive to the possibility of losing objects or money than they are to the possibility of gaining the same objects or amounts of money. We hypothesised that dopamine could be involved in the loss aversion behaviour. To highlight this, we have chosen a model of dopaminergic depletion : the Parkinson's disease The primary purpose of this protocol is to study the role of dopamine in the loss aversion phenomenon by comparing brain activity in parkinsonian patient with and without treatment with L Dopa, when they are exposed to mixed (gain/loss) gambles using money. The second purpose is to highlight the role of a dopamine depletion by comparing patient without treatment vs healthy paired control.
Efficacy of Cholecalciferol (Vitamin D3) for Delaying the Diagnosis of MS After a Clinically Isolated Syndrome (D-Lay-MS)
Mar 2013The main objective of this study is to evaluate the efficacy and tolerance of 2 years of treatment with cholecalciferol (vitamin D3) in patients with a clinically isolated syndrome at high risk for MS (CIS).
Sub-thalamic Nucleus Stimulation in Parkinson Disease (PARKEO)
Mar 2013Deep brain stimulation (DBS) is an established procedure for the symptomatic treatment of Parkinson's disease. This procedure performed in two steps using electrophysiology. This study is a prospective, randomized and monocentric study to compare two DBS procedures with or without electrophysiology. A better control of targeting and trajectory is necessary before not using electrophysiology, which is the reference procedure. A new definition of sub thalamic nuclei with new MRI stereotactic landmarks, the use of surgical robot (Neuromata Renishaw) and the use of operative imaging (O-arm) could allow the implantation of electrode in sub-thalamic nuclei without the need of electrophysiology. Two groups of patients will be followed: a first group of patients with a procedure under general anesthesia alone without electrophysiological stimulation and a second smaller group of patients with a first step of electrode implantation under awake surgery with electrophysiological stimulation followed by a second step under general anesthesia for the implantation of stimulator. Clinical results will be assessed at 6 months after implantation.
Assessment of Bone Marrow-derived Cellular Therapy in Progressive Multiple Sclerosis (ACTiMuS)
Mar 2013The investigators recently completed one of the first feasibility/safety trials in the world of reparative bone marrow cell therapy in 6 patients with longstanding MS (www.nature.com/clpt/journal/v87/n6/full/clpt201044a.html). Safety was confirmed, and intensive repeated tests on the patients measuring nerve conduction in various pathways in the brain and in the spinal cord showed statistically significant improvements at 12 months in every patient. While highly preliminary and involving only a very small number of patients, these results at least raise the possibility of a significant (though very partial) underlying repair effect within the damaged nervous system. The investigators believe this urgently requires further testing - both to accelerate benefit for patients, and to begin improving therapeutic efficacy. The investigators therefore propose a programme of translational and clinical stem cell research, aiming (1) to continue translation with a phase two controlled trial of bone marrow cells in patients with longstanding MS; and (2) to explore in parallel the potential mechanisms of action, by studying bone marrow cells from treated patients and control subjects, aiming to establish which of the various relevant bone marrow subpopulations contribute to efficacy, and which particular reparative mechanism(s) are important. The investigators hope these studies will not only confirm the therapeutic benefit of this approach, but also provide the basis for improving the magnitude and impact of this novel and exciting treatment modality.
Early Diagnosis of Alzheimer-like Dementia: Benefit of MRI and PET Imaging
Mar 2013The physio-pathology of Alzheimer's disease (AD) remains unknown and there is no cure. Thus, the search for objective markers of preclinical first signs of cognitive impairment, is currently a major public health issue. Early detection of the disease is a major challenge to hope to slow or even stop the neurodegenerative process before the stage of dementia. In AD the investigators observe: A reduction in the volume of brain hippocampi associated with an alteration of the diffusion of water molecules in the white matter. A structural brain degeneration coupled with a decrease in cerebral glucose metabolism. Recent publications show that cerebrospinal fluid (CSF)flow is also altered, probably due to dysfunction of the choroid plexus. Hence the potential interest to study is, in addition to conventional imaging, the imaging of CSF dynamics and choroid plexus metabolism. In that aim,the investigators use two imaging modalities: Magnetic resonance imaging (MRI) is used to assess blood and CSF flow in the brain Positron emission tomography (PET) is used to assess glucose metabolism in grey/white matter and also in choroid plexus. The investigators expect that, because of choroid plexus atrophy in AD, CSF flow would be altered as well as glucose metabolism dynamic in choroid plexus.
Foot Mechanical Stimulation for Treatment of Gait and Gait Related Disorders in Parkinson's Disease and Progressive Supranuclear Palsy (GONDOPARK)
Mar 2013The purpose of this research study is to evaluate safety and effectiveness of Foot Mechanical stimulation to improving Gait and Gait Related Disorders in Parkinson Disease and Progressive Supranuclear Palsy both stable and with motor fluctuation.
Agomelatine Treatment of Depression in Schizophrenia (AGOPSYCH)
Mar 2013Major depressive episodes (MDEs) occur frequently during the course of psychotic disorders, and several antidepressive agents have been successfully applied. The new melatonergic antidepressant agomelatine (AGO) appears promising for the treatment of MDEs in schizophrenia for several reasons. The investigators plan to test the efficacy and tolerability of AGO for antidepressive treatment in schizophrenia. For this task, the investigators plan to enrol 27 schizophrenic patients into an open, single-armed, prospective clinical trial with agomelatine.
Impact of CPAP Therapy in Obstructive Sleep Apnea on Parameters of Nocturnal Pulse Wave Analysis
Mar 2013The present study aims to document and assess changes in single parameters of pulse wave analysis (ASI single parameters) as well as to evaluate ASI cardiovascular risk assessment before initiation of CPAP therapy and after 6 months of CPAP therapy in patients with obstructive sleep apnea.
The Effect of Minocycline on Relapse After Successful Intravenous Ketamine/Minocycline-induced Symptoms Response in Subjects With Depression
Mar 2013The purpose of this study is to assess whether the antidepressant effect from intravenous (IV) ketamine treatment can be maintained by minocycline compared to placebo after IV ketamine treatment is stopped.
A Randomized, Open-Label Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Single and Multiple Doses of Armodafinil (50, 100, and 150 mg/day) in Children and Adolescents with Excessive Sleepiness Associated With Narcolepsy
Mar 2013The primary objective of this study is to characterize the single- and multiple-dose pharmacokinetics of armodafinil and its major circulating metabolites (R-modafinil acid and modafinil sulfone) in children and adolescents with excessive sleepiness associated with narcolepsy.
A Follow-up Study on Safety and Tolerability of Intracerebroventricular Administration of sNN0031 to Patients With Parkinson's Disease
Mar 2013The purpose of this study is to document the long-term safety and tolerability after intracerebroventricular (ICV) administration of sNN0031 (PDGF-BB) in patients who participated in study sNN0031-001
A First Time in Human Study Exploring Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK2618960 in Healthy Volunteers and Patients With Relapsing Remitting Multiple Sclerosis (RRMS)
Mar 2013This is a 3-part study where Parts A, B (single-blind - investigator and subject blind) will enrol healthy volunteers and Part C (open-label) will enrol RRMS patients. Parts A (single ascending dose) and B (repeat ascending dose) will assess safety, tolerability, PK and PD of GSK2618960. Part C (repeat doses) will assess safety, tolerability, PK, PD, immunogenicity, paraclinical (magnetic resonance imaging [MRI] lesion counts) disease activity and markers of Th1 and Th17 mechanisms. Part A: Each of the 24 healthy volunteers (divided in 5 groups), will take part in only 2 of the planned 8 dosing sessions (A-active, P-placebo). Subjects in each group of Part A will be randomized in a 2:1:1 ratio to one of the following sequences: AA, AP or PA such that in each dosing session they will receive study treatment in a 3:1 ratio of active: placebo respectively. Part B: Dosing levels and regimen are dependent upon safety tolerability and PK/receptor occupancy (RO) data from Part A. In Cohort 1, 12 subjects will be randomized in a 3:1 ratio to A or P. Each subject will receive the same study treatment for repeated doses. If the duration of full RO from highest dose in Part A is less than 4 weeks, a second cohort of 12 subjects in Part B may be recruited, based on Dose Escalation Committee (DEC) decision Part C: The 20 RRMS patients will be assigned to active treatments for 2 to 4 repeated doses. Safety/tolerability and PK data monitoring and the decision to proceed to the next dose level of GSK2618960, and the decisions to proceed to Part B and Part C of the study will be made by a dose escalation committee.
Internetbased Relapse Prevention for Partially Remitted Depression (ISAK)
Mar 2013The main purpose of the study is to test whether Internet-based relapse prevention plus medication has a better protective effect compared to medication only, for persons with residual depressive symptoms who are currently in paid employment or in education.
Longitudinal Therapeutically Non-interventional Study of MSRV-Env Burden in Normal Population (CONTROL)
Mar 2013This study intends to explore the levels of MSRV expression by analyzing the levels of MSRV transcripts in blood, as well as the levels of the MSRV-Env protein in serum in the normal population. This study is important for establishing a baseline to analyze results obtained in MS patients (another dedicated study is performed in parallel in MS patients). The study will be conducted over one year in a cohort of healthy subjects. The MSRV RNA level, MSRV-Env protein levels, reverse transcriptase activity, inflammatory markers assessed by cytokines levels will be analysed to define control levels in the normal population and their variation during one year. The data obtained in this study in healthy controls will be compared to those obtained in a parallel similar study, GN-E-002, conducted in different types of MS patients.
MIBRAIN - Migraine and the Brain: Consequences, Causes, and Vascular Interaction
Feb 2013Migraine is a very common, chronic/intermittent and disabling neurovascular headache disorder that has long believed to have no severe consequences. Recent evidence, however, strongly suggest that migraine is associated with increased risk of ischemic stroke and there is initial evidence that migraine is associated with structural brain changes independent of the occurrence of stroke. As migraine has strong links with the vascular system, it is plausible that vascular functions interact on the association between migraine and structural brain changes as well as cognition. Our primary objectives are to investigate: (i) the relationship of migraine and migraine subtypes on magnetic resonance imaging (MRI) changes in a cohort of patients with active migraine; (ii) the relationship of migraine on cognitive performance among patients with active migraine; and (iii) the relationship of migraine and migraine specifics with vascular functions and morbidity. As secondary objective, we investigate whether the association of migraine on structural brain changes or cognitive performance is modified by vascular functions.
Assessment of Attentional and Executive Disorders in Multiple Sclerosis Using Techniques of Virtual Reality (SEPREV)
Feb 2013Since many years cognitive disorders are a main topic of clinical research in Multiple Sclerosis (MS) as there could be observed early on in the disease and could induce with time in patients significant socio-professional burden. Today assessment of cognitive dysfunction in MS is still based on traditional pencil-paper task tests which are not able to give a true representation of functional burden observed in patients in real life situations. The development of new tools close to these "life situations", i.e. more ecological, are needed to better assess and take in charge cognitive impairment in MS patients. One way to reach this goal is Virtual Reality (VR). VR offers a new human-computer interface paradigm that simulates a realistic 3D environment where the user become immersed and interacts with it. These last ten years VR has known a rapid development in the health domain and has been applied with success to motor rehabilitation, psychiatry and neuropsychology. In this last domain, virtual environment (VE) reproducing activities of daily living have been used to evaluate executive and memory functions as well as attentional or visuospatial processes. Among main VE developed, driving assessment system, navigation skills, cooking behaviors, virtual supermarket have shown better sensitivity to detect functional consequences of cognitive impairment in various neurological and psychiatric disorders than traditional evaluations. In Caen University Hospital, investigators used VE driving system and developed the use of the Virtual Action Planning in a supermarket (VAP-S ; Klinger et al 2004) where a user move to select and buy groceries and other things inside an interactive virtual supermarket using a shopping cart. In a preliminary study investigators have used this virtual interactive tool to evaluate executive functioning in small group of Parkinson's disease and MS patients. Analysis of initial data shows the feasibility of the VAP-S for use with these two kinds of diseases. According to these results investigators planned a new study in Relapsing-Remitting(RR)- MS patients where they compare the use of VE (driving system and the VAP-S) to traditional attentional and executive evaluation for estimate their respective sensitivity to detect cognitive/functional impairment in MS patients. Investigators hope to shown that VR will demonstrate its interest to assess cognitive functions in MS and to develop cognitive rehabilitation.
Intraoperative MRI and 5-ALA Guidance to Improve the Extent of Resection in Brain Tumor Surgery (IMAGER)
Feb 2013The investigators hypothesize that the rate of radiologically complete resections of contrast-enhancing brain tumors following surgeries aided by use of 5-ALA induced fluorescence guidance and use of an intraoperative ultra-low field MRI is higher compared to surgeries aided by 5-ALA induced fluorescene alone.
Follow-up Study After 11 Years of Patients Who Were Included in the BENEFIT Trial (304747) With a First Demyelinating Event Suggestive of Multiple Sclerosis
Feb 2013This study assesses clinical and imaging long-term data, after early or delayed interferon-beta-1b treatment in patients with a first demyelinating event suggestive of multiple sclerosis (MS), 11 years after enrollment in the Betaferon/Betaseron in Newly Emerging Multiple Sclerosis for Initial Treatment (BENEFIT) study (304747). The main objectives are to describe the disease course, change in disability, cognitive function, resource use and employment status, in relation to Interferon beta-1b in the long term.
Essential Fatty Acids in Adult ADHD (OCEAN-GER)
Feb 2013The aim of this project is to investigate the effect of a dietary supplementation with essential fatty acids in adults on cognitive functions related to attention and impulse control in the general population and in individuals with a diagnosis of attention deficit hyperactivity disorder (ADHD).
Impact of Therapeutic Educational Programme on the Alzheimer's Disease Affected Patient's Quality of Life (THERAD)
Feb 2013Therapeutic education expands in Alzheimer's Disease management in France. Several studies revealed a positive impact on caregiver's burden and/or quality of life. The purpose of this study, is to determine whether a therapeutic educational programme for both AD patients and primary caregivers, in community dwelling, improves patient's quality of life.
Obstructive Sleep Apnoea in Patients With Intermittent Claudication (WITH-SAS)
Feb 2013The main aim of this study is to determine how common undiagnosed obstructive sleep apnoea is in individuals with intermittent claudication.
Neurodevelopmental Outcome of Early Dietary Lysine Restriction in Pyridoxine Dependent Epilepsy Patients (NOEL)
Feb 2013Restricting dietary lysine intake in infants from age 3 months or less with confirmed diagnosis of pyridoxine-dependent epilepsy due to Antiquitin (ATQ) deficiency will: reduce the accumulation of neurotoxic substratesα-aminoadipicsemialdehydeandits cyclic equivalent 1-piperideine-6-carboxylate;and will improve overall neurodevelopmental outcome at 3 years of age by acting as an effective intervention into the complex pathophysiology of the condition.
Efficacy of Omega-3/Omega-6 Fatty Acids in Pre-school Children at Risk for ADHD
Feb 2013The efficacy of PUFAs (as nutritional supplement) in/for pre-school children with ADHS symptoms will be evaluated in a randomised controlled doubleblind trail with children aged 3-6 years.
Multidisciplinary and Coordinated Follow-up Based on a Telemonitoring Web Platform for Improving CPAP Compliance in Low Cardiovascular Risk Sleep Apnea Patients : OPTISAS 1 Study
Feb 2013To compare 6-months CPAP compliance when Sleep Apnea patients at low cardiovascular risk are randomly allocated to usual CPAP care or a multidisciplinary and coordinated follow-up based on a telemonitoring web platform
Risk Factors of Complications Regarding Patients Undergoing Brain Tumour Neuro-surgery (Cranioscore).
Feb 2013Patients undergoing a brain tumour neurosurgery with craniotomy may present rare but lifethreatening post-operative complications. There are currently no strong recommendations to help the clinician in an attempt to properly hospitalise these patients after their intervention (Neuro-ICU, ICU,surgical ward). Determining risk factors of post-operative complications could optimise resources. Therefore hospitalisation in Neuro-ICU would be mandatory in only a little number of patients.
Targeted Hypoglossal Neurostimulation Study #2 (THN2)
Feb 2013The objective of the study is to confirm the safety and efficacy in patients utilizing the aura6000 System for the treatment of Obstructive Sleep Apnea (OSA).
Study of [11C]DPA-713 for Temporal Lobe Epilepsy
Feb 2013Some people with epilepsy have an epileptic focus, a small part of the brain that is the starting point of the seizure. This focus is like an irritant or an inflammation, and helps cause the seizure. People with epilepsy that affects the temporal lobe of the brain often have an epileptic focus. Researchers want to look at the epileptic focus by using a drug that attaches to a protein associated with inflammation. An imaging study with the drug will show how much inflammation is in the area of the brain where the seizures start. The drug, called [11C]DPA-713, will be tested for its effectiveness in people with temporal lobe epilepsy. Its effects will be compared with imaging studies given to healthy volunteers. The aim is to see if [11C]DPA-713 can show the inflammation in the epileptic focus of seizures.
A Study of RG7314 to Investigate Efficacy and Safety in Individuals With Autism Spectrum Disorders
Feb 2013This multi-center, randomized, double-blind, parallel group, placebo-controlled, proof of concept study will investigate the efficacy and safety of RG7314 in adult patients with autism spectrum disorders. In stage I of the study, patients will be randomized to receive daily oral doses of 1.5 mg RG7314or placebo for 12 weeks. After an independent safety review, the study may proceed to stage II. In stage II of the study, additional patients will be randomized to receive daily oral doses of 1.5mg, 4 mg of RG7314 or placebo for 12 weeks. After an interim efficacy and safety analysis, additional patients may be randomized to receive daily oral doses of 1.5 mg, 4 mg of RG7314 or placebo for 12 weeks. The anticipated time on study treatment is 12 weeks.
Presurgical Language Mapping With fMRI: Comparison of BOLD and fASL Techniques (MALTA)
Feb 2013One of the aim of the neurosurgical treatment of brain tumor is to offer the maximal resection with the minimal neurological risk. The presurgical mapping of eloquent areas with functional magnetic resonance imaging (fMRI) is helpful to plan the surgery. BOLD fMRI is now the gold standard to map language areas. However, BOLD signal is diminished near the brain tumor. It is now possible to detect cortical activation with arterial spin labeling (ASL) techniques, detecting variations of perfusion during an activation paradigm (fASL), fASL could be interesting to detect eloquent areas near a brain tumor.
EEG and Pharmacological Exploration of Executive Dysfunctions Induced by STN-DBS in PD (EEGDBSNAd)
Feb 2013Deep brain stimulation (DBS) of the subthalamic nucleus (STN) remarkably improves motor functions in patients with Parkinson disease (PD). However, growing evidence suggests that STN-DBS also causes executive inhibitory deficits and impulsive behaviour (Jahanshahi et al 2000; Schroeder et al 2002; Hershey et al 2004; Thobois et al 2007; Frank et al 2007; Ballanger et al., 2009). Despite a widespread use, the mechanisms of action of STN-DBS are still unclear. Two reasons might explain this. 1) From a theoretical point of view, cognitive models of executive control mechanisms are incomplete. 2) From a methodological point of view, investigating cerebral activity during STN-DBS is very limited because most techniques are incompatible with locally implanted electrodes. This project relies on a double opportunity to answer these questions offered by recent theoretical and methodological advances. First, investigations in healthy subjects (Jaffard et al 2007, 2008, Boulinguez et al 2009) revealed an essential function of inhibitory control, so far ignored, consisting in locking in advance movement triggering processes to prevent undesired automatic or anticipated responses to unattended stimuli. In other words, key processes of executive control may act tonically before stimulation occurs, calling brain imaging studies to look at proactive and not only reactive activations. Second, recent advances in EEG signal processing now allow suppressing from the electroencephalogram DBS-related artifacts (Allen et al. 2010), providing a tremendous opportunity to use a non-invasive technique with the high temporal resolution necessary to disentangle proactive from reactive brain activity. To our knowledge, up to date no study has been published using EEG with STN-DBS patients since Allen et al.'s paper. The first operational purpose of this project is to identify the anatomo-functional origin of STN-DBS-induced executive dysfunction using EEG recordings in classical stimulus-response tasks. Results expected from this first part of the project may help resolving other long-lasting issues. Indeed, reactivity as assessed by simple reaction time in non-implanted patients as well as impulsivity in STN-DBS patients are known to remain insensitive to dopaminergic medication. Since the proactive activity related to executive, inhibitory, control may be supported by the noradrenergic (NA) system, the second purpose of this project is to test the original hypothesis according to which NA plays a central role in both akinesia and STN-DBS side effects.
Role of Mesocorticolimbic Pathway in Apathy of Patients With Parkinson's Disease. - Study Using Diffusion Tensor Imaging and Fibres Tracking
Feb 2013The objective of this study is to explore, using diffusion weighted MRI, the regions of the brain which are proposed to play a role in motivation in apathetic Parkinson's disease patients and to define more precisely the relation between dopaminergic fibres and the meso-cortico-limbic system with the help of tractography methods
A Phase 4 Study to Assess the Impact of Patient Support Program on Health Related Quality of Life and Adherence in Subjects With Relapsing-Remitting Multiple Sclerosis Administered Rebif® With the RebiSmart™ Device (RebiQoL)
Feb 2013This is a randomized, comparative, and multicenter study to assess the impact of a patient support program (MinSupport Plus) on health related quality of life (HRQoL) and adherence in subjects with relapsing-remitting multiple sclerosis administered Rebif® with the RebiSmart™ device.
Safety Study of Olesoxime in Patients With Stable Relapsing Remitting Multiple Sclerosis Treated With Interferon Beta. (MSREPAIR)
Feb 2013This is a 24-week phase 1b, randomized, double-blind, placebo-controlled, parallel-group, multicenter safety study comparing the tolerance profile of olesoxime (495 mg, od) when administered on top of Interferon beta in patients with stable Relapsing Remitting Multiple Sclerosis. Patients will be randomly allocated to olesoxime (495 mg, od) or placebo in a 1:1 ratio.
The Effects of DHA on Attention Deficit and Hyperactivity Disorder (DADA)
Feb 2013The purpose of this study is to determine whether docosahexaenoic acid (DHA) is effective in reducing Attention Deficit/Hyperactivity Disorder (ADHD) core symptoms in a clinical sample of children and adolescents with ADHD.
Patient Narcoleptic Treated With BF2.649 (Pitolisant) in add-on to Sodium Oxybate (HARMONY IV)
Feb 2013This is a multicentric international phase III, double blind randomized study assessing efficacy and safety in parallel group of BF2.649 (pitolisant) compared to placebo in add-on to sodium oxybate of narcoleptic patients with residual Excessive Daytime Sleepiness (EDS) during 8 weeks
Gut-derived Neuropeptides in Cerebrospinal Fluid of Patients With Parkinson's Disease and Healthy Controls
Feb 2013Collection of CSF and serum samples in a standardized way in order to quantitatively measure the concentration of gut-derived peptides (ghrelin, leptin, glucose-dependent insulinotropic peptide [GIP], GLP-1, amylin, PP, peptide YY [PYY], and insulin). Scientific questions: Do CSF (and serum) concentrations of these gut peptides differ between PD patients and controls? Do CSF (and serum) concentrations of the investigated peptides correlate with clinical and / or epidemiological characteristics of the investigated subjects (age, gender, BMI, disease duration, severity of motor impairments, presence of non-motor symptoms, co-morbidities, medication, etc.)?
Monitoring Natural Killer Cells in Multiple Sclerosis Patients Treated With Fingolimod
Feb 2013Data on fingolimod effects on NK cells are so far conflicting. A longitudinal study on fingolimod treated kidney transplant patients showed that NK cells were not influenced in any of the treatment groups. However, more recent reports indicate an increased frequency of NK cells in peripheral blood and CSF of MS patients treated with fingolimod and a relative reduction of immature CD56bright NK cells in fingolimod-treated MS patients. It has been demonstrated that the expression of NK cell relevant sphingosine 1-phosphate (S1P) receptors seems to increase during NK cell maturation. Thus, different NK cell sub-types may response differently to S1P-receptor agonist such as fingolimod. Therefore, the investigators aim to investigate longitudinally (baseline vs. treatment) the effects of fingolimod on NK cell maturation/differentiation.
Aspirin Resistance and Sleep Apnea (AREAS)
Feb 2013The main objective of our study is to analyze the influence of sleep apnea on the response to antiplatelet therapy in stable aspirin-treated type-2 diabetes patients.
iCBT for Depression - Standard Versus Condensed Treatment Material (KONRAD)
Feb 2013In this study the investigators will assess reading speed and the ability to concentrate in all patients and then randomise them to an internet-based treatment for depression using either a standard material or a condensed one. The condensed material consists of 30000 words and will be available as text files and on audio files. The standard material consists of 60000 words and is only available as text files. Both groups will have the possibility of e-mail contact with a personal therapist during the treatment.
Interventional, open-label, flexible-dose extension study of brexpiprazole in patients with schizophrenia
Jan 2013The primary objective is to evaluate long-term safety and tolerability of brexpiprazole
Impact Of Closure Of Patent Foramen Ovale On Apnoea-Hypopnoea-Index, Nocturnal Hypoxemia And Systemic Vascular Function In Patients With Obstructive Sleep Apnoea
Jan 2013The purpose of this study in patients with obstructive sleep apnoea (OSA) and concomitant patent foramen ovale (PFO) is to assess the impact of percutaneous PFO closure on nocturnal hypoxemia and apnea/hypopnea, pulmonary and systemic artery pressure, endothelial function and arterial stiffness.
A 26-week, Multicenter, Open-label, Extension Study of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in Patients with Schizophrenia
Jan 2013The primary objective of this open-label trial is to evaluate the safety and tolerability of aripiprazole intramuscular (IM) depot administered for 26 weeks to subjects with schizophrenia.
Melatonin Dose-effect Relation in Childhood Autism (MELADOSE)
Jan 2013Melatonin is a neurohormone produced from serotonin which promotes sleep. The alterations in central and peripheral serotonin neurobiology and in circadian sleep-wake rhythms observed in autistic disorder suggest abnormalities in melatonin secretion. Several studies have reported a decrease in melatonin secretion in individuals with autism. Furthermore, nocturnal excretion of 6-Sulphatoxymelatonin (the predominant melatonin metabolite) was significantly negatively correlated with severity of autistic impairments in verbal communication and play. Melatonin could therefore have a therapeutic effect on sleep problems and may play a role in the pathophysiology of autistic disorder. These data highlight the possible therapeutic interest of an oral administration of melatonin in patients with autistic disorder. Thus, the objective of this clinical trial is to study the relation between the melatonin dose administered and its effect on severity of autistic impairments especially in verbal communication and play.
Post-reimbursement Study to Follow Spinal Neurostimulator Devices for Pain Therapy (SME)
Jan 2013Observational study to evaluate the long term efficacy of Spinal Cord Stimulation (SCS) over 2 years following SCS implant. This study is requested by French Health Authorities for reimbursement renewal, to maintain reimbursement for SCS in approved indication in France.
Subcutaneous Stimulation as Add on Therapy to Spinal Cord Stimulation (SCS) to Treat Low Back Pain in Failed Back Surgery Syndrome (FBSS) (SubQ Study)
Jan 2013Aim of the study Failed back surgery syndrome (FBSS) is a clinical entity consisting of chronic leg and /or back pain due to radicular nerve damage. The effectiveness of Spinal Cord Stimulation (SCS) in the pain management of patients with FBSS is proven. Patients mostly have dominant leg pain, however a significant percentage of FBSS patients has a more pronounced back pain and are commonly excluded from SCS as it is often inadequate in relieving both the back and leg pain components. Recently some reports showed the benefit of subcutaneous stimulation (SubQ) for low back pain in patients with FBSS. This has been confirmed by a feasibility study performed by our group. The aim of the randomized controlled study is to evaluate the effect of SubQ on low back pain in FBSS patients for whom SCS gives an inadequate back pain relief.
Central and Systemic Inflammation in Alzheimer's Disease (IMABio3)
Jan 2013The main objective of this study is to investigate the central and peripheral inflammatory, as well as the spontaneous Aβ-specific, immune responses at the asymptomatic stage and early stages of AD by combining molecular imaging techniques with blood biomarker analyses. The early and preclinical stages of AD will be studied in the relatives of patients with PSEN1, PSEN2 or APP mutations that are at-risk (50%) to be mutation carriers. This study will evaluate the contribution of Inflammatory and immune anti-Aβ responses (I2ARs) in AD progression. Inclusion of sporadic and familial forms of AD will aid in studying the chronology of pathological events. Clinical follow-ups will be conducted annually for two years and will include an MRI and a blood draw on the last visit. We expect I2ARs to appear in the early stages of the disease and to constitute new prognostic factors. I2ARs could also become therapeutic markers for the assessment of novel anti-amyloid treatments and may offer new insights to the development of Aβ-specific immunotherapy strategies.
A Randomised, Placebo-Controlled, Parellel-Group, Double-Blind Efficacy and Safety Trial of MK-8931 in Subjects with Mild to Moderate Alzheimer's Disease
Jan 2013To assess the efficacy of two doses of MK-8931 on cognition in sugjects with mild to moderate AD To assess the efficacy of two doses of MK8931 on functional ability in activities of daily living in subjects with mild to moderate AD To assess the safety and tolerability of threee doses of MK-8931 in the treatment of subjects with mild to moderate AD
Efficacy and Safety Study of Inhaled CVT 301 in Parkinson's Disease Patients for Treatment of OFF Episodes
Jan 2013This randomized, multicenter, placebo-controlled, double-blind study will evaluate the efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing motor response fluctuations (OFF phenomena) as an outpatient (i.e., at home) and in the clinic.
Sleep Apnoea Syndrome Without Chronic Heart Failure
Jan 2013It is the objective of this study to collect scientific data of sleep apnoea syndrome patients´ cardiac and respiratory function by additional sensors.
Cytochrome P450-2D6 Screening Among Elderly Using Antidepressants (CYSCE)
Jan 2013Depression is common among elderly with an estimated prevalence of 5%. Due to ageing the national burden will double in the coming decade. Antidepressants as TCAs and SSRIs are effective in reducing symptoms, especially in people with severe depression. To optimize treatment efficacy and reduce side effects, the Pharmacogenetics Working Group of the Royal Dutch Pharmacists Association developed guidelines for dose-adaptation, for instance for antidepressants such as nortriptyline and venlafaxine based on their main relevant genotype (CYP2D6) accompanied by Therapeutic Drug Monitoring. Such personalized drug dosing based on pharmacogenetic information at the start of therapy can speed up the titration phase of antidepressants to establish an adequate maintenance dose. However, pharmacogenetic screening programs are expensive and evidence on effects and costs of such a program among elderly antidepressant starters from randomized controlled studies is lacking. The investigators will conduct a pragmatic randomized controlled trial to determine the effects and costs of pharmacogenetic screening information to optimize drug dosing in depressed elderly patients who start with nortriptyline or venlafaxine. Objective: The primary objective is to determine the effects of pharmacogenetic screening for CYP2D6 on the time to reach adequate blood levels as an accepted proxy for adequate treatment. Secondary objectives include adverse drug reactions and cost-effectiveness
Biomarkers In Seizure To Predict Recurrence and Severe Outcomes (BISTRO)
Jan 2013We study the hypothesis that combination of Proteine S100 beta and Copeptin within normal ranges can rule out seizure recurrences and severe outcome, and allow early discharge from the emergency department
Cerebral Reorganization in Schizophrenia
Jan 2013The purpose of this study is to reveal the specific effects of computer-aided cognitive training on cerebral reorganization in schizophrenia
Neuroplasticity-oriented Cognitive Intervention in Early Onset and First Admission Schizophrenia
Jan 2013The purpose of this study is to reveal the specific effects of computer-aided cognitive training on course and rehabilitation in early onset schizophrenia
Effect of Deep Brain Stimulation on Gait of Patients With Parkinson's Disease Depending on Electrode Location in Subthalamic Area
Jan 2013Deep brain stimulation of STN (subthalamic nucleus) at high frequencies generally improved gait in parkinsonian patients. However, sometimes the investigators observed a gait aggravation either with using high voltage and high frequencies, either because of suboptimal placement of electrode inside Forel H2 field. The most frequent hypothesise to explain this gait aggravation is a modulation of the activity of pedunculopontine nucleus due to a diffusion of the electric stimulation current to the fibbers going near STN area. The primary purpose of this study is to compare the effect of deep brain stimulation with high frequency versus low frequency on gait of patients whatever the electrodes placement (STN ou Forel fields) and whatever the medication condition (with or without treatment).
Role of Dopamine on Loss Aversion Behaviour: Study on Parkinsonian Patients
Jan 2013The primary purpose of this protocol is to study the role of dopamine in the loss aversion phenomenon by comparing brain activity in parkinsonian patient with and without treatment with L Dopa, when they are exposed to mixed (gain/loss) gambles using money. The second purpose is to highlight the role of a dopamine depletion by comparing patient without treatment vs healthy paired control.
Deep Brain Stimulation of the Superolateral Branch of the Medial Forebrain Bundle (slMFB) for the Treatment of Refractory Major Depression (FORESEEII)
Jan 2013The investigators will investigate in a sham controlled staggered onset design antidepressant effects and safety of deep brain stimulation (DBS) to the superolateral branch of the main medial forebrain bundle (slMFB).
Respiratory Function and Walking Capacity in Multiple Sclerosis
Jan 2013Multiple sclerosis (MS) is a chronic progressive neurological disease. Respiratory dysfunction due to weakness in the respiratory musculature has been described in MS. This leads to increased morbidity and mortality in late stages of the disease. It is possible that respiratory dysfunction influence physical fitness in earlier stages as well. Walking disability and fatigue causes significant impact on health in patients with MS, even in earlier stages. The hypothesis is that there is a relationship between respiratory function, walking capacity and fatigue and that daily deep breathing exercise during two months will improve respiratory function, walking capacity and fatigue.
Study to Assess Whether GSK239512 Can Remyelinate Lesions in Subjects With Relapsing Remitting Multiple Sclerosis
Jan 2013This is a randomized, parallel group, placebo-controlled study designed to assess whether GSK239512 can enhance lesion remyelination in subjects with Relapsing Remitting Multiple Sclerosis (RRMS). Subjects with RRMS on stable background treatment with either Avonex (Interferon-beta1a) or Copaxone (Glatiramer Acetate) are eligible to participate. Subjects will be randomized in a 1:1 ratio between placebo and GSK239512, and will continue to be managed with their current standard of care therapy (Copaxone or Avonex). The total treatment period is 48 weeks, including a standard 4 week titration period and 44 week maintenance treatment period (which could be adapted to a 5-week titration and 43 week maintenance period, if needed). Titration doses start at 10 micrograms (mcg) and increase up to 80 mcg (10 mcg first week, 20 mcg second week, 40 mcg third week, 80 mcg fourth week). Subjects will be titrated to the maximum tolerated dose with the objective of titrating to the highest dose (80 mcg GSK239512), whenever possible, based on investigator judgement of tolerability. The post-treatment follow-up period will be a minimum of 2 weeks in duration following the end of treatment at Week 48 or early withdrawal, as appropriate.
Omega-3 Fatty Acids Supplementation in ADHD
Jan 2013The overarching aim of the proposed study is to assess whether omega-3 fatty acids supplementation can augment the effects of methylphenidate in children with ADHD. The investigators hypothesized that omega-3 fatty acids supplementation will be associated with improved ADHD symptoms.
Neurophysiological Molecular and Developmental Analysis of the Glutamate Synapse in Autism (NMDA-Autism)
Jan 2013Neurophysiological, Molecular and Developmental Analysis of the glutamate synapse in Autism
iMRI-guided Brain Biopsies
Jan 2013The aim of the study was to assess the safety and effectiveness of stereotactic brain tumour biopsy (STx biopsy) guided by low-field intraoperative MRI (iMRI) in comparison with its frameless classic analogue based on a prospective randomized trial.
Pharmacokinetics and safety of agomelatine in children (from 7 to less than 12 years) and adolescents (from 12 to less than 18 years) with Major Depressive Disorder. An open-labelled, multicenter, three-dose level, non-comparative study.
Jan 2013The primary objective is to evaluate pharmacokinetics of 3 doses of agomelatine in patients from 7 to less than 18 years suffering from Major Depressive Disorder.
A randomized, controlled, parallel group, double-blind, multi-centre, phase IIb study to assess safety and clinical activity of continued AFFITOPE® AD02 vaccinations of patients who participated in the AFFITOPE® AD02 phase II study AFF006.
Jan 2013To assess the longterm safety and tolerability of continued AFFITOPE® AD02 administrations following a predefined vaccination schedule (boosts at regular intervals after priming) over a total period of 37 months (includes the 18 months of the preceding AFF006 study). To assess the clinical activity (parameters for cognition and function) of vaccination with AFFITOPE® AD02 when extending the vaccination schedule applied within the preceding phase II study AFF006 by boosts at regular intervals (comparison to previous placebo patients now being vaccinated with verum).
Prevention of depression and poor physical function in older persons with vitamin D supplementation
Jan 2013The primary objective of the D-Vitaal trial is to answer the following two questions: 1. Does vitamin D supplementation decrease depressive symptoms in older persons? 2. Does vitamin D supplementation improve physical performance and decrease functional limitations in older persons?
Zonisamide for the Treatment of Obstructive Sleep Apnea in Overweight/Obese Patients
Jan 2013This RCT explores the efficacy of Zonisamide (Zonegran®)on overweight/obese in patients with moderate to severe obstructive sleep apnea. Patients will be randomized to receive zonisamide, placebo or nasal continuous positive airway pressure (nCPAP) during 4 weeks. A 5 month open extension part will follow when patients in the tablet groups will all receive zonisamide. Patients in the open CPAP group will continue with CPAP treatment. Study hypothesis: Controlled pharmacological weight reduction with Zonisamide will result in elimination of OSA and OSA sequels more effectively than nCPAP due to incomplete compliance with the mechanical treatment and a lack of direct beneficial metabolic effects after nCPAP. Further it is hypothesized that zonisamide has a direct pharmacological effect on respiratory control during sleep by its carbonic anhydrase inhibitory effects and this will result in a reduction of sleep disordered breathing.
Auricular Acupuncture and Cognitive Behavioral Therapy Treatment for Insomnia (NADA)
Jan 2013The aim of the study is to investigate if AA is as effective as CBT to treat insomnia for patients who have stopped using benzodiazepine-like sleep medicine.
Trial of Telephone-based Psychotherapy for Depression With and Without Adjunctive Supportive Mail (Tel-PT)
Jan 2013This study aims to compare the effectiveness of two telephone-based psychotherapy (Tel-PT) interventions for patients with mild to moderate depression. Both interventions consist of one personal session and weekly to bi-weekly 8-10 telephone sessions with a licensed cognitive-behavioral psychotherapist accompanied by the study of educational materials and the completion of regular monitoring questionnaires (total treatment duration: approximately 3 months). Patients are randomized into one of two conditions: Patients in the condition "Tel-PT including mail" additionally receive a motivating letter from their psychotherapist after each telephone session, while patients in the condition "Tel-PT without mail" receive no further interventions. Patients refusing to be randomized are to be assigned to the condition "Tel-PT without mail". This study takes place within a larger study evaluating a stepped care model for depression (01KQ1002B-TP7).
Evaluation of the Efficacy of Rasagiline in Apathy in Drug-naïve Patients With Parkinson's Disease by a Multi-center Study
Jan 2013Among the psychiatric symptoms observed in the premotor phase of Parkinson's disease (PD) and/or in "de novo" patients, apathy is relatively frequent (estimated to 23%). However, the neuropathological bases of apathy are still unknown. However, recent data suggests that apathy could be linked to a more specific dopaminergic denervation in the ventral striatum. Rasagiline increases the bioavailability of striatal endogenous dopamine by blocking the MAO-B. Some recent data suggest rasagiline could be effective to improve apathy in Parkinson's disease. The primary outcome is to demonstrate a significant reduction of apathy using the Lille apathy rating scale (LARS) in drug naive patients with early diagnosed Parkinson's disease, using a treatment by rasagiline.
Evaluation of the Efficacy of Rasagiline in Apathy in Drug-naïve Patients With Parkinson's Disease by a Multi-center Study
Jan 2013Among the psychiatric symptoms observed in the premotor phase of Parkinson's disease (PD) and/or in "de novo" patients, apathy is relatively frequent (estimated to 23%). However, the neuropathological bases of apathy are still unknown. However, recent data suggests that apathy could be linked to a more specific dopaminergic denervation in the ventral striatum. Rasagiline increases the bioavailability of striatal endogenous dopamine by blocking the MAO-B. Some recent data suggest rasagiline could be effective to improve apathy in Parkinson's disease. The primary outcome is to demonstrate a significant reduction of apathy using the Lille apathy rating scale (LARS) in drug naive patients with early diagnosed Parkinson's disease, using a treatment by rasagiline.
Raltegravir (Isentress) Pilot Study in Relapsing Multiple Sclerosis (INSPIRE)
Jan 2013The purpose of this study is to determine whether raltegravir is effective in preventing progression of relapsing remitting multiple sclerosis as determined by gadolinium- enhanced MRI.
Prevention of Oxaliplatin-induced Neuropathic Pain by a Specific Diet (NEUROXAPOL)
Jan 2013Use lay language. Oxaliplatin is a reference anticancer drug in the treatment of colorectal cancer. However, its use is hampered by a specific neurotoxicity, which is characterized by acute thermal hypersensitivity, notably to cold temperatures, and by chronic neuropathy appearing with the repetition of chemotherapy cycles. To this date there is no effective therapy able to prevent and/or to treat these adverse drug reactions. So oncologists are sometimes strained to decrease anticancer doses or to stop chemotherapy; Previously, a polyamine deficient diet has been able to prevent acute oxaliplatin-induced hypersensitivity in animals. So we hypothesizes that a specific nutritional therapy, a polyamine deprived diet, may prevent acute oxaliplatin-induced hypersensitivity in patients.
A Randomized Double Blind Placebo Controlled Parallel Group Study of the Efficacy and Safety of Pregabalin (BID) in Subjects with Post-Traumatic Peripheral Neuropathic Pain
Jan 2013To evaluate the efficacy of pregabalin (150-600 mg/day) compared with placebo in the treatment of chronic post-traumatic peripheral neuropatic pain
A Controlled Clinical Trial of Cathodal Transcranial Direct Current Stimulation in Patients With Refractory Epilepsy
Jan 2013There is a continuous necessity for the search of new alternatives for safe, affordable and effective noninvasive therapies for patients that are not eligible for focal resective or palliative surgery. The transcranial direct current stimulation (tDCS) therapy has demonstrated to be safe, noninvasive, simple and effective with promising results in case series, case reports and animals models for the treatment of intractable epilepsy. tDCS is a feasible and low cost method to modify cortical excitability in a non-invasive procedure. Its effects on cortical excitability seem to be similar to the effects induced by repetitive transcranial magnetic stimulation. The aim of this study is determine the safety and efficacy in the reduction of the number of seizures (>50%) and epileptiform activity in patients with refractory and multifocal epilepsy after different protocols of tDCS compared with placebo.
Effectiveness of Betaserc® (Betahistine Dihydrochloride) in Patients With Vestibular Vertigo in Routine Practice (VIRTUOSO)
Dec 2012The purposes of this international post-marketing observational program is to investigate effectiveness of betahistine dihydrochloride (Betaserc®) tablets and assess the course of vestibular vertigo after treatment discontinuation in population of Russia and Ukraine outpatients suffering from vestibular vertigo in pragmatic clinical settings. Exploratory analyses of results from both participating countries may be expected to provide insights about the subjective circumstances of vestibular vertigo patients in a wider than usual range of gender, underlying ICD-10 diagnosis, national and cultural situations.
The Relationship of Essential Fatty Acids to Adult ADHD: The OCEAN Study (Oils and Cognitive Effects in Adult ADHD Neurodevelopment)
Dec 2012The aim of the study is to provide preliminary data on the relationship of Essential Fatty Acids (EFAs) to cognitive and electrophysiological measures of brain and behavioural functions in adults with attention deficit hyperactivity disorder (ADHD) and controls. This main aim will be achieved in two ways. First the investigators will measure the relationship of the various measures to blood levels of EFAs in ADHD cases and controls. Secondly, the potential effects of dietary supplementation with EFAs on cognitive-electrophysiological and behavioural measures in ADHD cases will be investigated. We will evaluate the extent to which changes in neuronal activity and cognitive performance are related to behavioural and functional measures over time. This is to be carried out by conducting a randomised controlled trial of fish oil supplementation in adults with ADHD (The OCEAN study: Oils and Cognitive Effects in Adult Neurodevelopment).
A Multicenter, Multinational, Double-blind, Placebo-controlled, 3-arm Phase 4 Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease- Associated Apathy, Motor Symptoms, and Mood
Nov 2012To assess the effects of rotigotine over placebo on improvement of apathy and motor symptoms in subjects with early-stage and advanced stage idiopathic Parkinson?s disease
Contribution of High Resolution EEG Functional Connectivity Measures to Presurgical Evaluation of Patients With Intractable Epilepsy (conneXion)
Nov 2012Electroencephalography (EEG) with very high spatial resolution (HR-EEG, 256 electrodes) allow for better analysis of local and global activity of the cerebral cortex, as compared with conventional EEG. Since January 2012, the Neurology Department of CHU Rennes is the first clinical service in France equipped with such a system. Applied to HR-EEG recordings, brain connectivity methods are likely to provide essential information (in the form of "connectivity graphs") on cortical networks, either dysfunctional or not, involved in the generation of interictal paroxysms (like spikes or spike-waves) and during seizures. So far, many methods have been proposed (see for a review: Wendling et al., 2009; Wendling et al., 2010). However, since each method is highly sensitive to the type of model that is assumed for the underlying relationship between distinct brain regions (Ansari-Asl et al., 2006), none of them has yet demonstrated its effectiveness.
A Phase IV Acceptability and Feasibility Trial of the Effects of Medication on Memory in Idiopathic Nondementing Parkinson’s Disease.
Nov 2012This is a feasibility study designed to inform the following process / primary outcomes: • to obtain estimates of memory performance which will inform a power calculation; • to explore with patient-participants and carers barriers to participation which include management of symptoms during washout period. This will be achieved formally using the end of study focus group as well as informally during mid-and end of study clinic visits with clinical members of research team, and during ON/OFF research visits with the PhD student/assessor.
Efficacy and safety of a fixed combination of cinnarizine 20 mg and dimenhydrinate 40 mg vs betahistine dihydrochloride 16 mg in patients with vertigo of peripheral origin. A multi-centre, double-blind, randomised, active-controlled, stratified two-parallel group clinical study
Nov 2012The main objective is to demonstrate that the antivertiginous efficacy of the fixed combination cinnarizine/dimenhydrinate is non-inferior to betahistine dihydrochloride 16 mg in patients suffering from vertigo of peripheral origin.
A European multicenre double-blind placebo controlled phase III trial of nilvadipine in mild to moderate Alzheimer's disease.
Nov 2012To investigate the efficacy of Nilvadipine as a disease course modifying treatment for mild to moderate AD in a phase III double-blind placebo-controlled study. To investigate the safety profile of Nilvadipine in patients with mild to moderate AD.
A 12-week, Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in the Acute Treatment of Adults With Schizophrenia
Nov 2012To evaluate the overall efficacy of aripiprazole IM depot as acute treatment in subjects with schizophrenia.
A Multicenter, Multinational, Double-blind, Placebo-controlled, 2-arm Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain
Nov 2012To assess the effects of Rotigotine over placebo on improvement of Parkinson’s disease associated chronic pain in subjects with advanced-stage Parkinson’s disease experiencing Parkinson’s disease associated chronic pain.
Double blind randomized study to assess the efficacy of BF2.649 compared to placebo in add-on to sodium oxybate in the treatment of narcoleptic patients with residual excessive daytime sleepiness (EDS) during 8 weeks.
Nov 2012To show relevant beneficial effect of BF2.649 on EDS compared to placebo in add on to sodium oxybate in narcoleptic patients with residual EDS. This trial will characterize the efficacy of BF2.649 compared to placebo in showing an incremental improvement to the situation achieved by the use of sodium oxybate particularly in terms of a reduction of EDS as measured by the Epworth Sleepiness scale (ESS). In addition the change in the average number of cataplexy attacks per week will be assessed.
Relapse prevention in children and adolescents with DSM-IV-TR conduct disorder treated with risperidone: a randomised, double-blind, placebo-controlled discontinuation study.
Nov 2012The primary objective is to test the hypothesis that, after at least 16 weeks of daily administration (4 for titration, 12 of relatively stable dose, 4 of which at fixed doses; Study Period 1), risperidone given orally at a dose of 0.25-3.0 mg/day depending on body weight (equivalent to approximately 0.01-0.04 mg/kg/day is superior to placebo in preventing relapse of the symptoms of conduct disorder as assessed through a 12 week double-blind discontinuation trial (Study Period 2) of children and adolescents with conduct disorder and no developmental delay/mental retardation. This will be measured by comparing the mean change from the double-blind baseline to endpoint in the Nisonger Child Behaviour Rating Form Typical IQ version-ODD/CD disruptive behaviour composite total score (Aman et al., 2008) using all investigator ratings, based on all available information.
A Study to Assess Learning Performance in Patients With Schizophrenia and Young and Elderly Healthy Volunteers
Nov 2012The purpose of this study is to measure and contrast implicit and explicit learning performance in patients with schizophrenia relative to young and elderly healthy volunteers.
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 18-Month Safety and Efficacy Study of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Mild Alzheimer’s Disease
Nov 20121. To demonstrate the clinical efficacy of leuco-methylthioninium bis(hydromethanesulfonate) (also known as LMTM, TRx0237) in mild Alzheimer’s disease as assessed by change from baseline on: • Alzheimer’s Disease Assessment Scale – Cognitive Subscale (ADAS-cog11) • Alzheimer’s Disease Cooperative Study – Clinical Global Impression of Change (ADCS-CGIC) - independently rated 2. To evaluate the effect of LMTM on Alzheimer’s disease modification as evidenced by reduction in decline in glucose uptake in the temporal lobe on 18F-flurodeoxyglucose positron emission tomography (FDG-PET) / computerized tomography (CT) imaging 3. To assess the safety and tolerability of LMTM 200 mg/day given for up to 78 weeks
Ascending Multiple-Doses of AMG 334 in Healthy Subjects and in Migraine Patients
Nov 2012The primary purpose of this study is to determine whether AMG 334 is safe and well tolerated in healthy subjects and migraine patients. As part of the secondary objectives, this study will be conducted to characterize the pharmacokinetic (PK) profile of AMG 334 after multiple SC doses in healthy subjects and migraine patients, as well as to characterize the effect of AMG 334 on the capsaicin induced increase in dermal blood flow after multiple SC doses in healthy subjects and migraine patients.
Improving Work Outcome for People With Severe Mental Illness
Nov 2012The purpose of this study is to investigate the efficacy of IPS in Denmark and compare effects of 1. Individual Placement and Support (IPS) vs. 2. IPS + cognitive remediation and work-related social skills training vs. 3. standard intervention, among individuals with severe mental illness.
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Month Trial of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Mild to Moderate Alzheimer's Disease
Nov 20121. To demonstrate the clinical efficacy of at least one dose level of TRx0237 in mild to moderate Alzheimer’s disease as assessed by change from baseline on: • Alzheimer’s Disease Assessment Scale – Cognitive Subscale (ADAS-cog11) • Alzheimer’s Disease Cooperative Study – Clinical Global Impression of Change (ADCS-CGIC) - independently rated 2. To determine the safety and tolerability of TRx0237 150 and 250 mg/day
Obstructive Sleep Apnea Syndrome (OSA) and Getemed (GETEMED)
Oct 2012It is often clinically impossible to differentiate children with an isolated snoring from those with OSA. The diagnosis of OSA is currently based on nocturnal, laboratory-based polysomnography. This expensive examination is poorly accessible due to appointments delays at hospital. Our study is designed to compare the characteristics of a home polysomnography versus standard polysomnography for the diagnosis of pediatric OSA.
A pilot study of Concerta XL in adult offenders with ADHD
Oct 2012The main question is to evaluate the effectiveness of a standard treatment for ADHD on behavioural problems, that are associated with ADHD in young male prisoners. The primary question is whether there is a decrease in aggressive behaviour following treatment of ADHD in a prison setting. Aggression is one of the main problem behaviours within the prison and previous research has shown the strong link between ADHD and aggression within adult prison populations.
Randomized, placebo-controlled and double blind clinical trial to assess the efficacy of ubidecarenone in patients diagnosed with fibromyalgia
Oct 2012To compare the efficacy of coenzyme Q10 versus placebo in patients diagnosed with fibromyalgia in terms of clinical response measured by means of the Fibromyalgia Impact Questionnaire (FIQ)
Multimodal Imaging in Pre-surgical Evaluation of Epilepsy (EPIMAGE)
Oct 2012Epilepsy is the most common chronic neurological disorder in the world, affecting more than 50 million people worldwide. Approximately 35% of patients with epilepsy are refractory to all available antiepileptic drugs. Drug-resistant epilepsies are often partial or focal. Patients with drug-resistant focal epilepsy suffer from an increased risk of death, primarily due to seizure-related fatalities, in comparison with the general population. The only therapeutic option for this form of epilepsy is the surgical removal of the region of the brain responsible for seizures, called the epileptogenic zone (EZ). This requires the precise localization of the EZ based on a comprehensive pre-surgical evaluation of patients. Today the gold standard for localizing the EZ and validating a non-invasive technique for localization of the EZ remains intracerebral stereo-EEG (stereo-electroencephalography or SEEG) recordings of spontaneous seizures. The implementation strategy of the intracerebral depth electrodes is guided by clinical and neuroimaging data, including anatomical Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET) with FDG (fluoro-Deoxy-Glucose) and MagnetoEncephaloGraphy (MEG). Although the contribution of each technique in the pre-surgical localization of the EZ has already been shown, no wide-scale study has examined the cumulative contribution of these three techniques.
ITT-PMS Extension An extension study of intrathecal therapy with monoclonal antibodies in progressive multiple sclerosis
Oct 2012To assess long-term stabilising effects of on neurological symptoms by regular IT administered monoclonal antibodies in MS.
Re-irradiation of High Grade Gliomas: a Quality of Life Study
Oct 2012Patients with a high grade glioma have an increasing overall survival and progression free survival after initial treatment. Because of a better performance status these patients are more often eligible for re-treatment with for example radiotherapy. However, to date only a few prospective studies on re-irradiation of gliomas exist and very little is known about the effects of re-irradiation on quality of life and cognition. This trial is designed to longitudinally establish the effects of re-irradiation on quality of life, cognition and physical performance in patients with a high grade glioma. Based on the currently available information the investigators hypothesize that quality of life after re-irradiation can be kept stable until further tumour progression.
A 6 months, randomized, multicenter, parallel-group, open-label study to evaluate the effect of an individualized patient support program on treatment satisfaction in Fingolimod (FTY720)-treated patients with relapsing-remitting multiple sclerosis
Oct 2012To evaluate the effect of an individualized patient support program vs. a standard patient support program on treatment satisfaction, measured by a treatment satisfaction questionnaire (TSQM-9) in Fingolimod-treated patients with relapsing-remitting multiple sclerosis over 6 months.
Effect of fingolimod on cardiac autonomic regulation in MS-patients
Oct 2012To evaluate whether fingolimod has an effect on the heart rate variability or myocardial ventricular repolarisation in patients with multiple sclerosis?
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Once a Day, TAK-375 (Ramelteon) Tablet for Sublingual Administration (TAK-375SL Tablet) 0.1 mg and 0.4 mg as an Adjunctive Therapy in the Treatment of Acute Depressive Episodes Associated With Bipolar 1 Disorder in Adult Subjects
Oct 2012To evaluate the efficacy of TAK-375SL tablet 0.1 mg and 0.4 mg once daily at bedtime (QHS) compared with placebo as assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS) after 6 weeks of treatment in subjects with acute depressive episodes associated with Bipolar 1 Disorder.
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Safety and Efficacy Study of Oral ELND005 as an Adjunctive Maintenance Treatment in Patients with Bipolar I Disorder
Oct 2012To assess the efficacy of ELND005 compared to placebo as adjunctive maintenance therapy in patients with BPD I. To assess the safety and tolerability of ELND005 in BPD I patients.
Randomised double-blind, placebo-controlled, cross-over study comparing the effects of single dose and repeated dosing treatment for 14 days of vestipitant / paroxetine combination in an enriched population of subjects with tinnitus and hearing loss
Sep 2012To measure the change in tinnitus loudness (VAS) after single (Day 1) and repeated (Day 14) administration of either vestipitant-paroxetine combination, or vestipitant alone vs. placebo.
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of the Safety and Efficacy of a Single Treatment of AGN-214868 in Patients With Postherpetic Neuralgia
Sep 2012To evaluate the safety, tolerability, and efficacy of AGN-214868 compared with placebo in the treatment of postherpetic neuralgia (PHN).
Normalization of dyrk1A and APP Function as an Approach to Improve Cognitive Performance and Decelerate AD Progression in DS Subjects: Epigallocatechin Gallate as Therapeutic Tool
Sep 2012Epigallocatechin-3-gallate (EGCG), the major catechin in green tea, is postulated to modulate dual specificity tyrosine-phosphorylation-regulated kinase 1A (DYRK1A) and amyloid beta precursor protein (APP) gene overexpression in the brains of Down syndrome mouse models. The clinical study is aimed at demonstrating that normalization of Dyrk1A and APP functions is a therapeutic approach to improve cognitive performance and decelerate AD (Alzheimer's disease) like progression.
Phase shift in adult ADHD of sleep and apetite.
Sep 2012To investigate the best treatment of the Delayed Sleep Phase Syndrome in adults with ADHD.
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABT 126 in Subjects with Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors
Sep 2012The objective of this study is to evaluate the efficacy and safety of two doses of ABT-126 in subjects with mild-to-moderate Alzheimer's disease (AD) taking doses of AChEIs
Sumatriptan non-responders: evaluation of a possible biomarker
Sep 2012Investigate the effect of sumatriptan and placebo on the rise of dermal blood flow caused by capsaicin application and iontophoresis of normal saline.
Histopathologic Evaluation of High Grade Brain Tumors by High Order Diffusion Tensor Imaging (TeDi-C2)
Sep 2012This study will examine the use of a variation of standard magnetic resonance imaging (MRI) called diffusion tensor MRI (DT-MRI), in order to evaluate the peripheral white matter infiltration of high grade brain tumors. Organized architecture is destroyed once brain tumor cells are infiltrating surrounding tissue. The infiltrated tissue is then isotropic (or less anisotropic). DT-MRI can assess anisotropy after datasets post treatment. Primary outcome is to find if a correlation exists between GA (generalized anisotropy) and the infiltration percentage of stereotactic peritumoral biopsies.
A multicenter, open-label, long-term safety extension of phase II studies ABE4869G and ABE4955G in patients with mild to moderate alzheimer’s disease
Sep 2012To assess the long-term safety and tolerability of crenezumab administered subcutaneously (SC) every 2 weeks (q2w) or intravenously (IV) every 4 weeks (q4w), in eligible patients with Alzheimer’s disease who participated in Study ABE4869g or ABE4955g and completed the Week 73 study visit, including brain MRI.
Phase-1 Study of Folinic Acid to Modulate MGMT Gene in Glioblastoma (FOLAGLI)
Sep 2012O6-méthylguanine méthyltransférase (MGMT) is the main repair gene after DNA lesion induced by Temozolomide in combination with radiation therapy of Glioblastoma (GBM) in Stupp.R et al published regimen. In preclinical models, it has been demonstrated that MGMT methylation (which is silencing the DNA repair process) is achievable by folic acid. About half of the patients with operated GBM have an un-methylated MGMT gene status and therefore a poorer prognosis. A phase-1 dose escalation study is proposed with pharmacologic doses of folinic acid in combination with temozolomide and radiotherapy of operated GBM.
Apathy in Schizophrenia
Sep 2012Apathy, defined as a quantitative reduction of voluntary, goal-directed behaviours (GDB), is a core component of negative symptoms. It has been suggested that the physiopathology of apathy is not a single entity but may be multiple, depending on which specific process or macrofunction is disrupted during completion of GDB. In line with this notion, Levy and Dubois proposed dividing apathic syndromes into three subtypes of disrupted processing: 'a-motivation', 'cognitive inertia', and 'uncoupling'. In schizophrenia, apathy has been associated with executive dysfunction, functional impairment and poor outcome. However, the neurobiological underpinnings of apathy in schizophrenia are poorly understood. Primary objective: confirm that chronic schizophrenic patients are apathic compared to healthy volunteers
A phase II, multicentre, randomised, double-blind, parallel group, placebo-controlled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis
Sep 2012To evaluate the safety, tolerability and effects of three oral doses of MT-1303 compared to placebo given for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis (RRMS) on MRI parameters.
An extension open-label safety study of a 24-month 20mg dose regimen of tasimelteon for the treatment of non-24-hour sleep-wake disorder (n24hswd) in blind individuals with no light perception who have enrolled in other tasimelteon clinical trials
Aug 2012The primary objective of this study is to characterize the effect of tasimelteon, 20 mg/night for 24 months, on standard measures of subject safety.
A randomized, double blind study comparing BF2.649 (Pitolisant) to placebo in two parallel groups on the weekly frequency of cataplexy attacks and Excessive Daytime Sleepiness in narcoleptic patients with cataplexy
Aug 2012The main objective is the measure of the anticataplectic efficacy of BF2.649 compared to placebo, assessed by the change in the average number of cataplexy attacks per week between the 2 weeks of baseline and the 4 weeks of stable treatment period.
Multicenter, randomized, double-blind clinical trial to compare the clinical and radiological efficacy of 625 mg vs 1250 mg of oral methylprednisolone in patients with multiple sclerosis in relapse.
Aug 2012To assess the non-inferiority of clinical and radiological efficacy of the treatment with lower-high dose of oMP (625mg/day for 3 days) vs high dose of oMP (1250mg/day for 3 days) in patients in relapse of MS, 28 days after the treatment.
FDDNP-PET for in vivo diagnosis of Tauopathy in unclassifiable parkinsonism
Aug 2012To assess the ability to detect in vivo underlying tau pathology in unclassifiable parkinsonism by means of [18F]-FDDNP
The SPD489-322 Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexible Dose Titration, Efficacy and Safety Study of SPD489 in Combination with an Antidepressant in the Treatment of Adults with Major Depressive Disorder with Inadequate Response to Prospective Treatment with an Antidepressant
Aug 2012The primary objective is to demonstrate the efficacy of SPD489 when used as augmentation therapy in the treatment of major depressive disorder (MDD) in inadequate responders following an 8-week course of treatment with an antidepressant, as measured by the mean change in Montgomery-?sberg Depression Rating Scale (MADRS) total scores.
Guided Self-Help for Parents of Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
Aug 2012Cognitive-behavioral based guided self-help for parents of adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD) is investigated in a feasibility and effectiveness study. The treatment is offered under routine-care conditions of the health-care system in Germany. Practicability, treatment participation and effectiveness is documented and tested in a one-group pre-test/post-test design.
Effect of Brivaracetam (BRV) on Nonpsychotic Behavioral Side Effects in Subjects Treated Previously With Levetiracetam (LEV)
Jul 2012Trial N01395 is to evaluate the reduction of nonpsychotic behavioral side effects in subjects with Epilepsy who switched to BRV 200 mg/day after discontinuing LEV due to such side effects; as well as the efficacy, safety and tolerability of BRV. No statistical hypothesis testing will be performed.
Repetitive Transcranial Magnetic Stimulation With Double Cone Coil in Chronic Tinnitus (Ti-CDC)
Jul 2012Transcranial Magnetic Stimulation is used to modulate both the auditory neural pathways contributing to the perception of phantom sounds, and the regulatory neural network responsible for the generation of the individual amount of suffering caused by chronic tinnitus.
efficacy of rotigotine on gait performance of parkinsonian patients
Jul 2012Patients suffering for Idiopathic Parkinson’s Disease. H&Y stage > or = 2 with un-satisfactory control by on-going pharmacological therapy (Levodopa, COMT & MAO-inhibitors), characterised by an incomplete control of motor signs, in particular presence of early morning akinesia, as well as gait deficits in the morning.
Efficacy and safety of 3 doses of S 38093 (2, 5 and 20 mg/day) versus placebo, in co-administration with donepezil (10 mg/day) in patients with moderate Alzheimer’s Disease. A 24-week international, multi-centre, randomised, double-blind, placebo-controlled phase IIb study.
Jul 2012To assess the efficacy of 3 fixed doses of S 38093 (2, 5 and 20mg/ day) versus placebo, in co-administration with donepezil 10 mg/day, after 24 weeks of treatment, on cognitive performance measured with the ADAS-Cog 11-items in patients with moderate Alzheimers' Disease
Pulmonary Rehabilitation: Effects on Cognitive Functioning, Mood, Anxiety, and Quality of Life in Patients With COPD
Jul 2012The purpose of this project is to investigate whether a 12-week, fulltime pulmonary rehabilitation program can enhance cognitive functioning, mood, anxiety, and quality of life in patients with Chronic Obstructive Pulmonary Disease (COPD).
NOA-12: BIBF1120 and R-RT in Glioblastoma
Jul 2012Patients with glioblastoma at first or second progression who have failed standard treatment that must have included radiochemotherapy with temozolomide and who are a candidate for a reirradiation can be included into the trial. In the phase I part the minimal tolerated dose (MTD)of BIBF 1120 in combination with radiotherapy will be investigated. Subjects in phase II will be randomised to receive reirradiation alone or reirradiation + 2 x MTD BIBF1120.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Exploratory Study to Assess the Effect of Treatment With Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Walking Ability and Balance in Subjects with Multiple Sclerosis (MOBILE)
Jul 2012The objectives of this study in MS subjects treated with prolonged-release fampridine 10 mg twice daily compared with subjects treated with placebo are: To assess the effect of prolonged-release fampridine over 24 weeks on the following parameters to explore endpoints for the Phase 3 study: self-assessed walking disability, dynamic and static balance, subjective impression of well-being, subjects’ global impression of change in walking To evaluate the safety and tolerability of prolonged-release fampridine.
A randomised phase 2 trial investigating the additional benefit of hydroxychloroquine(HCQ) to short course radiotherapy (SCRT) in patients aged 70 years and older with high grade gliomas (HGG)
Jul 2012To examine the effect on one year survival of giving hydroxychloroquine (HCQ) with short course radiotherapy (SCRT) to high grade gliomas (HGG) patients aged ≥ 70 years
A Phase III clinical trial evaluating DCVax®-L, autologous dendritic cells (DC) pulsed with tumor lysate antigen for the treatment of glioblastoma multiforme (GBM)
Jul 2012The primary objective of this study is to compare progression free survival (PFS) between patients in the DCVax-L cohort and patients in the placebo cohort
A Randomized, Double-blind, Placebo-controlled, Dose-ranging, Parallel-group Study of the Safety and Efficacy of ABT-126 in the Treatment of Cognitive Deficits in Schizophrenia (CDS)
Jul 2012Evaluate the efficacy and safety of ABT-126 in the treatment of cognitive deficits in schizophrenia (CDS).
Efficacy and safety of lidocaine 5% medicated plaster in localized chronic post-operative neuropathic pain
Jul 2012The primary objective is to assess the superiority of the analgesic efficacy of lidocaine 5% medicated plaster in comparison to placebo in subjects with moderate to severe localized chronic post-operative neuropathic pain (PoNP).
An Non-Interventional Study of Patients With Persistent Symptoms of Schizophrenia
Jul 2012This multicenter, prospective, non-interventional study will evaluate the prevalence and characteristics of patients with persistent symptoms of schizophrenia and the course of their illness over 24 months.
Cupping in Fibromyalgia (CuFib)
Jul 2012The purpose of this randomized controlled study is to determine the effectiveness of cupping in patients with fibromyalgia compared to sham cupping.
A Double-Blind, Placebo-Controlled, Randomised, 4-Week Safety and Tolerability Study of LMTM in Subjects with Mild to Moderate Alzheimer’s Disease on Pre-Existing Stable Acetylcholinesterase Inhibitor and/or Memantine Therapy
Jun 2012To assess the safety and tolerability of leuco-methylthioninium bis(hydromethanesulfonate) (LMTM) 250 mg daily when co-administered with an acetylcholinesterase inhibitor (AChEI) and/or memantine to patients with mild to moderate Alzheimer’s disease. As exploratory objectives, markers of monoamine oxidase (MAO) inhibition will be assessed and blood samples collected for separate population pharmacokinetic analysis.
Propofol vs. Ketamin
Jun 2012Better therapeutic effect of ketamin in the treatment of ECT
A Phase 2, 4 Week Randomized, Double-Blind, Parallel Group, Placebo Controlled Proof of Concept Study to Evaluate Efficacy, Safety and Tolerability of GRC 17536 in Patients with Painful Diabetic Peripheral Neuropathy
Jun 2012To assess the efficacy of GRC 17536 in the treatment of pain associated with diabetic peripheral neuropathy (DPN).
Efficacy Study of Relaxation to 12 Weeks Against Placebo in the Overall Care Chronic Pain in Patients With Fibromyalgia (Sophrodol-1)
Jun 2012The main objective of this protocol is to measure the improvement of the overall situation of patients with diffuse chronic pain or fibromyalgia to 12 weeks by non-drug treatment relaxation. Secondarily,is to evaluate the evolution of physical variables, psychological and social improvement of the quality of life. To evaluate the evolution of drug consumption
Immunomodulating and neuroprotective properties of autologous multipotent mesenchymal stem cells in patients with multiple sclerosis - A randomised placebo-controlled double-blinded phase II study
Jun 2012To assess the effect of intra-venously applied autologous MSCs on cerebral inflammation in multiple sclerosis patients
A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study of the Safety and Efficacy of Memantine in Pediatric Patients with Autism, Asperger’s Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) Previously Treated with Memantine
Jun 2012To evaluate the safety, tolerability, and efficacy of memantine therapy compared with placebo in pediatric patients with autism, Asperger’s Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) previously on stable memantine therapy utilizing a randomized withdrawal paradigm.
An Open-Label Study Of The Safety And Tolerability Of Memantine In Pediatric Patients With Autism, Asperger’s Disorder, Or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
Jun 2012The objective of this study is to evaluate the safety and tolerability of memantine in pediatric (6-12 years old) patients with autism, Asperger’s Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) and to identify responders for participation in the follow-up randomized withdrawal study
Validation Study for an Unobtrusive Online Sleep Measurement System
Jun 2012The purpose of the study is to determine the precision of an unobtrusive sleep measurement system. The system measures a force sensor signal under the mattress and analyzes sleep quality. The system measures: time in bed, sleep stages, sleep fragmentation, heart rate, respiration rate, sleep related breathing disorders, and limb movements.
Assessment of Safety, Tolerability, and Pharmacodynamic Effects of LY2886721 in Patients with Mild Cognitive Impairment Due to Alzheimer’s Disease or Mild Alzheimer's Disease
Jun 2012The primary objective of this study is to assess the CSF PD effect of different LY2886721 doses in patients with MCI due to AD or mild AD compared to placebo, measured by change of CSF Aβ1-40 and Aβ1-42 concentrations from baseline to Week 12 and Week 26.
An Open-Label Safety Study of USL261 in the Outpatient Treatment of Subjects with Seizure Clusters
Jun 2012To evaluate the long-term safety and tolerability of USL-261 in the treatment of seizure clusters using the following: • Occurrence of respiratory depression after study drug administration (defined as < 8 breaths per minute and/or a sustained decrease in respiratory effort requiring emergency rescue treatment with assisted breathing or intubation). • AEs • Clinical laboratory measurements. • OAA/S Sum Score and Composite Scores at the end of the seizure cluster (within 6 hours after study drug administration). • Physical, nasal, and neurological examinations. • Vital sign measurements. • C-SSRS • Requirement for ER or EMS visits.
Long-Term Safety and Tolerability of ABT-126 in Subjects with Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors: An Open-Label Extension Study for Subjects Completing Study M11-793
Jun 2012Evaluate the long-term safety and tolerability of ABT-126 in subjects with mild-to-moderate Alzheimer's disease (AD) taking doses of AChEIs in a 28-week open-label extension of Study M11-793.
MRI-perfusion and FLT- and FET-PET during bevacizumab monotherapy for patients with recurrent Glioblastoma Multiforme
Jun 2012Determine changes in tumor perfusion parameters defined by perfusion MRI and changes in tumor proliferation defined by FLT- and FET-PET
Enhancement of Methylphenidate Treatment by Psychosocial Intervention and Support
Jun 2012The main purpose of this study is to evaluate the effectiveness of a parenting enhancement training (PET) for parents with children diagnosed with Attention Deficit-/Hyperactivity Disorder (ADHD) who are already medicated with methylphenidate.
Chronification and reversibility of migraine
May 2012We want to study the success rate of OAHM withdrawal in patients with chronic migraine related to support by a headache nurse, and onabotulinum toxin A injections during the withdrawal period, and the influence of comorbid depression.
Insight in Persons Presenting Schizophrenia or Related Troubles During Hospitalization in Psychiatry
May 2012Therapeutic alliance, and drug observance are major difficulties in the care of persons presenting schizophrenic symptomatology. They appear to be linked to insight, the consciousness that one has of his troubles. Nurse care in psychiatry aims at improving it, but usually without using specific evaluation tool. Insight is usually not evaluated during care, and its evolution is also not known, although it is highly probable that a positive evolution of insight for a person in hospital correlated to an adapted and optimal care by the medical and nursing teams. The investigators do not know examples of insight evaluation during a sequence of hospital care, or any evidence of insight variation in relation to evolution abilities of some schizophrenic patients cared in hospital. The investigators propose here to evaluate insight in people presenting schizophrenia or related troubles, at the beginning of hospitalization (I1) and 1 month later (I2), to better characterize insight variations, and identify the sociodemographic, clinical and therapeutic variables linked to it.
An exploratory, randomized, double blind, placebo controlled, parallel groups Phase II clinical trial to evaluate the efficacy and safety of E-52862 (400 mg) by oral route, in patients with postherpetic neuralgia (PHN).
May 2012The primary objective of this study is to assess the analgesic efficacy of E-52862 in subjects with moderate to severe postherpetic neuralgia
A Multicenter, Open-Label, Flexible-Dose Extension Study of Lurasidone Adjunctive to Lithium or Divalproex in Subjects with Bipolar I Disorder
May 2012The primary objective of the study is to evaluate the longer term safety and tolerability of lurasidone flexibly dosed at 20, 40, 60 or 80 mg/day over a 12-week period in subjects with bipolar I disorder who have previously been treated with lurasidone.
A Phase IIA, Multi centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Effect of 8 Weeks Treatment with Oral AZD3241 on Microglia Activation, as Measured by Positron Emission Tomography (PET), in Patients with Parkinson’s Disease
May 2012To evaluate the effect of 8 weeks treatment with AZD3241 on microglia activation as measured by [11C]PBR28 binding to TSPO.
Long-Term Safety and Tolerability of ABT-126 in Subjects with Mild-to-Moderate Alzheimer’s Disease: An Open-Label Extension Study for Subjects Completing Study M10-985.
May 2012The objective of this study is to evaluate the long-term safety and tolerability of ABT-126 in subjects with mild-to-moderate AD in a 28-week, open-label extension of Study M10-985.
A multi-center, randomized, double-blind, parallel group, placebo controlled, study in patients with non-chronic migraine to assess the efficacy, safety and tolerability of BID oral doses of BGG492 in migraine prevention
May 2012To assess the efficacy of BGG492 vs. placebo in terms of 50% responder rate (defined by ≥ 50% reduction in attack frequency during the last 4-weeks of the 12-weeks treatment period compared with the 4-weeks Baseline period).
A pragmatic randomised controlled trial comparing the effectiveness and cost effectiveness of levetiracetam and zonisamide versus standard treatments for epilepsy: a comparison of Standard And New Antiepileptic Drugs (SANAD-II)
May 2012Arm A - To compare the clinical and cost-effectiveness of initiating monotherapy with lamotrigine, levetiracetam or zonisamide in patients with untreated focal onset seizures. Arm B - To compare the clinical and cost-effectiveness of initiating monotherapy with levetiracetam or valproate in patients with untreated generalised onset seizures or untreated seizures that are difficult to classify.
An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF with Adjuvant Temozolomide in Patients with Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma (The “ACT IV” Study)
May 2012The primary objective of the study is to confirm that the addition of rindopepimut/GM-CSF to adjuvant temozolomide improves overall survival in patients with newly diagnosed, resected, EGFRvIII positive glioblastoma who have undergone gross-total resection.
A randomised, double blind, placebo controlled trial to evaluate the effect of Rivastigmine on gait in people with Parkinson’s disease who have fallen.
May 2012This study seeks to assess the benefit of rivastigmine (a drug which augments mental function) on gait (walking) dysfunction in patients with Parkinson’s disease (PD) with a past history of a fall. The primary aim is to determine the effect of the cholinesterase inhibitor (ChEi) rivastigmine on step time variability in patients with PD. Step time variability is a marker of how stable an individual's walking is and a prognostic marker for future falls risk.
Ketamine augmentation of ECT to improve outcomes in depression
May 2012Ketamine vs saline treatment will reduce ECT-induced cognitive impairments as measured by being able to learn new verbal information (anterograde verbal memory), remember personal events from their past (autobiographical memory) and saying the names of objects fluently (verbal fluency)
A Placebo-Controlled, Randomised, Double-Blind Trial to Assess the Safety and Efficacy of Intermittent Bilateral Intraputamenal Glial Cell Line-Derived Neurotrophic Factor (GDNF) Infusions Administered via Convection Enhanced Delivery (CED) in Subjects with Parkinson’s Disease
May 2012To assess the effect of q2 weekly intermittent bilateral intraputamenal GDNF infusions on OFF-state motor function at 9 months.
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Referenced, Flexible Dose Study on the Efficacy of Lu AA21004 on Cognitive Dysfunction in Adult Subjects with Major Depressive Disorder (MDD)
Apr 2012To evaluate the efficacy of treatment with flexible doses of Lu AA21004 (10 or 20 mg QD) versus placebo on cognitive dysfunction in patients with MDD.
An Open-Label, Multicenter, Single-Arm Study to Evaluate the Reduction in Nonpsychotic Behavioral Side Effects in Subjects with Epilepsy Switching from Levetiracetam to Brivaracetam due to Nonpsychotic Behavioral Side Effects
Apr 2012To evaluate the reduction of nonpsychotic behavioral side effects in subjects with epilepsy who switched to BRV 200mg/day after discontinuing LEV 1g/day to 3g/day due to these nonpsychotic behavioral side effects
A randomized, double-blind, placebo-controlled, multicenter phase II study evaluating the efficacy and safety of onartuzumab in combination with bevacizumab or onartuzumab monotherapy in patients with recurrent glioblastoma
Apr 2012• To evaluate the efficacy of onartuzumab + bevacizumab relative to placebo + bevacizumab as measured by investigator-assessed progression-free survival (PFS) • To evaluate the efficacy of onartuzumab + bevacizumab relative to placebo + bevacizumab as measured by investigator-assessed PFS in the subgroup of patients with Met-positive (Met+) glioblastoma
Interventional randomised, double-blind, parallel-group, placebo-controlled, exploratory study investigating the effects of Lu AA21004 on cognition and BOLD fMRI signals in subjects remitted from depression and controls
Apr 2012• to determine whether Lu AA21004 compared to placebo in subjects remitted from depression modulates the blood oxygen level dependent (BOLD) signal in functional magnetic resonance imaging (fMRI) of the brain areas associated with executive function (working memory) during performance of the N-back task. The regions of interest are within the prefrontal cortex and anterior cingulate • to determine whether Lu AA21004 compared to placebo in subjects remitted from depression modulates the blood oxygen level dependent (BOLD) signal in functional magnetic resonance imaging (fMRI) of the brain areas associated with spatial memory during performance of the Arena task., The region of interest is hippocampus • to evaluate the effects of Lu AA21004 compared to placebo in subjects remitted from depression on the BOLD signal in fMRI in other brain regions involved in the regulation of cognitive processes during working memory and planning performance (N-back and Arena task)
A randomized, double-blind, placebo-controlled, parallel group, dose ranging study to assess the effect of repeat doses of GSK962040 on the pharmacokinetics of levodopa in subjects with Parkinson’s disease exhibiting delayed gastric emptying
Apr 2012To measure the effect of co-administration of GSK962040 on levodopa pharmacokinetic exposure in subjects with Parkinson’s disease with delayed gastric emptying
QUTENZA versus pregabalin in subjects with peripheral neuropathic pain: an open-label, randomized, multicenter, noninferiority efficacy and tolerability study
Apr 2012To compare the efficacy of QUTENZA versus pregabalin in subjects with peripheral neuropathic pain (PNP) after 8 weeks
An exploratory, randomized, double blind, placebo controlled, parallel groups Phase II clinical trial to evaluate the efficacy and safety of E-52862 (400 mg) by oral route, in patients with painful diabetic neuropathy.
Apr 2012The primary objective of this study is to assess the analgesic efficacy of E-52862 in subjects with moderate to severe painful diabetic neuropathy.
A 1-week, open-label, multi-center study to explore conduction abnormalities during first dose administration of fingolimod in patients with relapsing-remitting multiple sclerosis (START)
Apr 2012To evaluate the incidence of patients with bradycardia (heart rate < 40 beats per min) and bradyarrhythmic ECG events during 6-hour monitoring period as measured by heart rate and second and third-degree AV blocks after treatment initiation of fingolimod 0.5 mg.
Evaluation of the efficacy of memantine in the treatment of fibromyalgia: a double-blind randomized control clinical trial.
Apr 2012To evaluate the efficacy of memantine in the treatment of pain
Effect of V0251 in Acute Vertigo
Apr 2012Assessment of efficacy and tolerance of a new anti-dizziness drug in acute vertigo.
A double-blind, placebo-controlled, multicenter, parallel group study to assess efficacy, safety and tolerability of TC-5619 as augmentation therapy to improve negative symptoms and cognition in outpatients with schizophrenia
Apr 2012To assess the efficacy of TC-5619 to improve negative symptoms and cognition when used as augmentation therapy to atypical antipsychotics in stable outpatients with schizophrenia
A Multicenter, Double-Blind, Placebo-Controlled Study of JNJ-40411813 as Adjunctive Treatment to an Antidepressant in Adults with Major Depressive Disorder with Anxiety Symptoms
Apr 2012To evaluate the efficacy, as assessed by the change from baseline on a 6-item subscale derived from the Hamilton Anxiety Scale (HAM-A6), and overall safety and tolerability of treatment with adjunctive JNJ-40411813 compared to placebo in patients with MDD with anxiety symptoms being treated with an antidepressant.
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABT 126 in Subjects with Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors
Mar 2012The objective of this study is to evaluate the efficacy and safety of two doses of ABT-126 in subjects with mild-to-moderate Alzheimer's disease (AD) taking doses of AChEIs.
A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis
Mar 2012The objectives of the study are to evaluate the safety, tolerability, and efficacy of 3 doses of AVP-923 capsules containing either 45 mg DM and 10 mg Q (AVP-923-45) or 30 mg DM 10 mg Q (AVP-923-30) or 20 mg DM and 10 mg Q (AVP-923-20) compared to placebo, for the treatment of central neuropathic pain in a population of patients with multiple sclerosis (MS) over a 12-week period.
A multi centre, double blind, randomised, placebo controlled crossover study to evaluate the efficacy and tolerability of picotamide in the prophylaxis of migraine in patients presenting with migraine with aura
Mar 2012To investigate the efficacy of picotamide compared to placebo in the reduction of the number of auras in patients with migraine with aura
Medication Adherence in Individuals With Epilepsy
Mar 2012The specific aims of the proposed research are: - To test the hypothesis that there will be a main effect of information, motivation and behavioral skills, on adherence behavior, and that a mediation model will show that information and motivation effects are partially mediated through behavioral skills. - To identify self regulation strategies and their situational cues (good opportunities, facilitators, and barriers) for medication adherence among individuals with epilepsy to better describe best practices and challenges.
A Randomized, Multicenter, Double-Blind, Non-inferiority Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Subjects with Schizophrenia
Mar 2012To demonstrate, in patients stabilized on the paliperidone palmitate 1 month formulation (PP1M), that paliperidone palmitate 3 month formulation (PP3M) is not less effective than PP1M in the treatment of symptoms of schizophrenia, based on the Kaplan-Meier 48-week cumulative estimate of survival (ie, percentage of subjects remaining relapse free).
Neuro-Music Therapy for Recent Onset Tinnitus: Evaluation of a Therapy Concept
Mar 2012To date, the pharmacological treatment options for tinnitus are unsatisfactory. For acute tinnitus drug treatments are only rated as being successful in approximately half of all cases. Therefore, the purpose of this study is to evaluate a neuro-music therapeutic approach (the "Heidelberg Model of Music Therapy") as a new treatment option for patients with recent onset tinnitus after initial medical treatment has failed.
A Non-Drug Study of The Suitability of Neurocognitive Tests And Functioning Scales For The Measurement of Cognitive And Functioning Changes in Individuals With Down Syndrome
Mar 2012This non-drug, longitudinal, multi-center, multi-national study will evaluate the suitability of neurocognitive tests and functioning scales for the measurement of cognitive and functioning changes in individuals with Down Syndrome. Tests will be administered at clinic visits in Weeks 1, (4) and 24. The duration of the study for each individual will be between 24 and 27 weeks.
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Add-on AMG 747 on Schizophrenia Negative Symptoms (Study 299)
Mar 2012To evaluate the treatment effect of AMG 747 compared to placebo on negative symptoms as measured by the Negative Symptom Assessment Scale (NSA-16) in patients with schizophrenia stabilized with ongoing antipsychotic therapy
A Randomized, Multicenter, Double-Blind, Non-inferiority Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Subjects with Schizophrenia
Mar 2012To demonstrate, in patients stabilized on the paliperidone palmitate 1 month formulation (PP1M), that paliperidone palmitate 3 month formulation (PP3M) is not less effective than PP1M in the treatment of symptoms of schizophrenia, based on the Kaplan-Meier 48-week cumulative estimate of survival (ie, percentage of subjects remaining relapse free).
Efficacy and safety of delta-9-tetrahydrocannabinol (delta-THC) in pain and pain related behavioural disturbances in dementia
Mar 2012The primary objective is to evaluate the efficacy of Namisol® on pain related behavioural disturbances, such as agitation, aggression and aberrant motor disturbances in patients with dementia, when added to an analgesic treatment with acetaminophen.
The Effects of Long-acting Methylphenidate on Academic Activity and Related Constructs in Children with ADHD: A Randomised Placebo Controlled Trial
Mar 2012The primary objective of this study is to explore the relationship between MPH and academic activity and the mediating roles of ADHD behaviours, cognitive deficits and motivational deficits in this relationship. Therefore, the direct effects of MPH on ADHD behaviours, cognitive deficits and motivational deficits are taken into account. In particular, evidence on the effects of MPH on motivational deficits in ADHD is scarce. It is hypothesized that treatment with MPH results in increased academic activity as compared to placebo control. If MPH improves academic activity, comparisons with the control group will be made to see if academic activity in children with ADHD normalises when treated with MPH.
Serum Profile of Inflammatory Factors, Immune and Angiogenic in Temporal Lobe Epilepsy: New Targets for Diagnosis and Prediction of Drug Resistance
Mar 2012Epilepsy affects 0.7% of the general population and 15-20% of patients develop drug resistance. The temporal lobe epilepsy (TLE) is the most common symptomatic focal epilepsies with a particularly high rate of drug (about 20 to 30%). In this type of epilepsy, where feasible, surgical removal of the home is the best therapeutic outcome. Mechanisms of epileptogenesis and drug resistance are still mysterious. Of recent clinical and experimental studies have shown that dysfunction of the blood-brain barrier (BBB) contributes to epileptogenesis and drug resistance. It is now recognized that cytokines exacerbate the excitability and permeability of the BBB, which was recently confirmed by studies showing that treatment of inflammation reduces epileptogenesis. Moreover, we have described an association between pathological angiogenesis and BBB permeability in the tissue of patients with excision of drug-resistant TLE. With experimental models, it was revealed an activation of the VEGF-VEGFR2 by seizures leading to rapid degradation of the BBB. The investigators hypothesis is that the identification of factors involved in BBB permeability may designate potential targets for drug-resistant partial epilepsy.
Ketamine in treatment resistant major depression (TRD)
Mar 2012Effectiveness of a single i.v. application of the NMDA antagonist ketamine at subanaesthetic doses will be tested The study will extend prior reports of open label studies in exploratory sample sizes to a double blinded placebo controlled study on a larger sample of 40 patients.
Effects of agomelatine versus escitalopram on emotional experiences in outpatients suffering from Major Depressive Disorder. An exploratory, randomised, double-blind, international, multicentre study with parallel groups: agomelatine (25 to 50 mg/day) versus escitalopram (10 to 20 mg/day) over a 6- month period.
Mar 2012The purpose of this exploratory study is to differentiate the effect of two antidepressants, agomelatine versus escitalopram, on the emotional experiences in outpatients suffering from Major Depressive Disorder.
A Double-Blind, Double-Randomization, Placebo-Controlled Study of the Efficacy of Intravenous Esketamine in Adult Subjects with Treatment-Resistant Depression
Mar 2012The primary objective of the study is to evaluate the efficacy, safety, and tolerability of esketamine in subjects with treatment resistant depression. Efficacy in improving symptoms compared with a placebo will be assessed by the changes from randomisation to end of week 1 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score.
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Add-on AMG 747 on Schizophrenia Negative Symptoms (Study 165)
Mar 2012To evaluate the treatment effect of AMG 747 compared to placebo on negative symptoms as measured by the Negative Symptom Assessment Scale (NSA-16) in patients with schizophrenia stabilized with ongoing antipsychotic therapy
The Parkinson's Progression Markers Initiative (PPMI)
Mar 2012To identify clinical, imaging and biologic markers pf Parkinson Disease (PD) progression for use in clinical trials of disease-modifying therapies.
An Open-Label Safety Study of USL261 in the Outpatient Treatment of Subjects with Seizure Clusters
Mar 2012To evaluate the long-term safety and tolerability of USL-261 in the treatment of seizure clusters using the following: - Occurrence of respiratory depression after study drug administration (defined as < 8 breaths per minute and/or a sustained decrease in respiratory effort requiring emergency rescue treatment with assisted breathing or intubation). - AEs - Clinical laboratory measurements. - OAA/S Sum Score and Composite Scores at the end of the seizure cluster (within 6 hours after study drug administration). - Physical, nasal, and neurological examinations. - Vital sign measurements. - C-SSRS - Requirement for ER or EMS visits.
Rationalisation of antipsychotic drug use in older people, using [18F]-Fallypride PET
Feb 2012(i)To investigate differences in regional dopamine D2/3 receptor occupancy between Alzheimer's Disease, Schizophrenia Like Psychosis and Healthy Controls after 4 days treatment with amisulpride 50mg daily (ii)To investigate differences in the threshold of dopamine D2/3 receptor occupancy required for 25% symptom reduction and emergence of motor side effects in SLP and AD during 4-10 weeks treatment with amisulpride (50-200mg daily) (iii) To determine dose-response relationships (dose/plasma level/clinical outcome) in SLP and AD during dose-titration of amisulpride (50-200mg) over 4-10 weeks
Evaluation of the CR Neuromodulation Treatment for Tinnitus (RESET2)
Feb 2012The purpose of this study is to determine whether a new device delivering a sound-based intervention (termed acoustic coordinated reset neuromodulation) has significant clinical benefit for people with intrusive tinnitus. It is hypothesised that the particular pattern of sound stimulation delivered by the device acts to break up patterns of synchronous nerve firing in the brain that may be responsible for the sensation of tinnitus. We will also measure brain activity in a subset of participants to determine if the intervention results in changes in brainwave activity.
An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias
Feb 2012To evaluate the long-term safety and tolerability of AFQ056 in patients with PD-LID as assessed by •Incidence and severity of adverse events and serious adverse events •Changes in vital signs, laboratory assessments, and ECGs •Changes in underlying symptoms of PD as measured by the UPDRS (Unified Parkinson’s Disease Rating Scale) part III (Motor Examination) and AEs potentially related to an exacerbation of the movement disorder of PD
A Phase 2b, Randomized, Double Blind, Placebo Controlled, Parallel Group, Dose Ranging Study to Evaluate the Efficacy and Safety of VX-765 in Subjects With Treatment Resistant Partial Epilepsy With a 24-Week Open-Label Extension
Feb 2012To evaluate the efficacy, safety, and tolerability of VX-765 to treat seizures in subjects with treatment resistant partial epilepsy
A Sleep Laboratory Study to Investigate the Safety and Efficacy of the Rotigotine Skin Patch in Subjects With Restless Legs Syndrome and End-Stage Renal Disease Requiring Hemodialysis
Feb 2012This is a sleep laboratory study to evaluate the efficacy and safety of Rotigotine in subjects with Restless Legs Syndrome and End-Stage Renal Disease requiring hemodialysis. The objectives are to demonstrate superiority of Rotigotine against Placebo as well as to investigate the effect of Rotigotine on quality of life and sleep.
A double blind, randomized, placebo controlled, crossover study of the effectiveness of oral fampridine in improving upper limb function in progressive multiple sclerosis.
Feb 2012To assess the effect of treatment with fampridine in patients with secondary progressive MS (SPMS) or primary progressive MS (PPMS) with upper limb dysfunction (as defined by a 9-HPT time of between 15-90 seconds) and Kurtzke EDSS scores in the range 4.0-7.0 on 1. Upper limb function assessed by the nine-hole peg test (9-HPT) and the Jebson Taylor Hand Function Test (JTT). 2. Scores of the MSIS-29 (physical), MSWS-12 and the Disabilities of the Arm, Shoulder and Hand Score (DASH)
Effects of agomelatine (25 to 50 mg/day) on circadian rhythms in patients with Major Depressive Disorder. An exploratory 6-week open, flexible dose, international multicentre, non comparative study.
Feb 2012Assess the effect of agomelatine on the circadian rhythms in Major Depressive Disorder patients by evaluating circadian parameters.
13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of modified release AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease
Feb 2012To assess how titration of modified release AFQ056 at 2-week intervals to a target dose of 200 mg b.i.d. or 150 mg b.i.d. versus placebo affects the tolerability profile in patients with moderate to severe PD-LID. To demonstrate the anti-dyskinetic efficacy, as measured by change from baseline to Week 12 in the modified AIMS (Abnormal Involuntary Movement Scale) total score, of titration of modified release AFQ056 at 2-week intervals to a target dose of 200 mg b.i.d. or 150 mg b.i.d. versus placebo in patients with moderate to severe PD-LID.
13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of modified release AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease
Feb 2012To assess how titration of modified release AFQ056 at 2-week intervals to a target dose of 200 mg b.i.d. or 150 mg b.i.d. versus placebo affects the tolerability profile in patients with moderate to severe PD-LID. To demonstrate the anti-dyskinetic efficacy, as measured by change from baseline to Week 12 in the modified AIMS (Abnormal Involuntary Movement Scale) total score, of titration of modified release AFQ056 at 2-week intervals to a target dose of 200 mg b.i.d. or 150 mg b.i.d. versus placebo in patients with moderate to severe PD-LID.
A Phase IIa, Multicenter, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-6096 for Treatment Augmentation in Patients with Major Depressive Disorder.
Jan 2012(1) To evaluate the efficacy of MK-6096 in comparison with placebo as treatment augmentation for patients with MDD, based on change from baseline to week 6 in MADRS total score. (2) To assess the safety and tolerability of MK-6096 as augmentation therapy for patients with MDD.
Adults With Attention Deficit Hyperactivity Disorder (ADHD): Validation of a Clinical Interview and Screening Instruments in French
Jan 2012ADHD is a neurodevelopmental disorder that affects about 5% of school-age children and 3.5% of adults worldwide. This condition is under-recognised in France and other European countries and, therefore, under-diagnosed. As part of the European Network for Adult ADHD, the investigators translated into French a structure interview called the Diagnostic Interview for Adult ADHD (DIVA). The investigators also translated rating scales such as the ASRS and the WURS. Validation studies are rare in France. The aim of this study is to include two groups of 50 adults whether they have or not ADHD with respect of Diagnostic and Statistical Manual - Revision 4(DSM-IV) criteria as implemented in the DIVA (i.e. actual at adulthood and past in childhood). Subjects have to fill out a booklet of questionnaires including the WHO's Adult ADHD Symptom Rating Scale (ASRS) (screening tool for actual diagnosis) and the Wender Utah Rating Scale (WURS, a screening tool for ADHD in childhood with respect of the Utah criteria). The investigator will be able to compare the actual criteria for ADHD between the ASRS and the DIVA, and the past criteria for ADHD between the WURS and the DIVA. Finally, an estimate of the prevalence of ADHD in adults will be computed.
A Phase 2 Study of LY2157299 Monohydrate Monotherapy or LY2157299 Monohydrate plus Lomustine Therapy compared to Lomustine Monotherapy in Patients with Recurrent Glioblastoma
Jan 2012Overall Survival
An open-label study to compare the prognostic value of (18F)Flutemetamol PET-imaging with longitudinal biomarker data in healthy volunteers and patients with mild cognitive impairment
Jan 2012To examine the efficacy of raised [18F]Flutemetamol brain uptake for differentiating subjects with mild cognitive impairment (MCI), who subsequently will develop Alzheimer’s disease (AD), from patients with MCI who will be cognitively stable or develop other dementias than AD
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of RO4995819 Versus Placebo, as Adjunctive Therapy in Patients with Major Depressive Disorder Having Inadequate Response to Ongoing Antidepressant Treatment
Jan 2012To evaluate the efficacy of 6 weeks treatment of RO4995819 versus placebo as adjunctive therapy in patients with MDD having inadequate response to ongoing antidepressant treatment based on mean change in Montgomery Asberg Depression Rating Scale (MADRS) scores from baseline to end of treatment.
The ACER-study - the effects of galantamine on the variability and stability of walking among patients with Alzheimer's disease.
Jan 2012The main objective of the present study is to examine the effects of treatment with galantamine among patients with AD on the variability and stability of walking (with and without dual-task), functional mobility, standing balance, and cognitive functions (e.g. attention and executive functions).
Gabapentin in the disorder of the impulse control in the Parkinson´s Disease: multicentric study, double-blind, randomized, controlled with placebo.
Jan 2012To study the efficay of gabapentin versus placebo in the disorder of impulse control in the Parkinson´s disease, using for its evaluation the Questionnaire for Impulsive-Compulsive Disorder in Parkinson´s Disease.
A multi-center, randomized, double-blind, placebo-controlled, parallel group, polysomnography study to investigate safety and efficacy of the rotigotine transdermal patch in subjects with Restless Legs Syndrome and End-Stage Renal Disease requiring hemodialysis
Jan 2012The primary objective of this trial is to demonstrate superiority of rotigotine against placebo in subjects with RLS and ESRD requiring hemodialysis.
Effect of reduced cholinergic transmission by rocuronium on the hypoxic ventilatory response in patients with obstructive sleep apnea - before and after three months of continous positive airway pressure treatment. A non-radomised, non-blinded study
Jan 2012How does residual neuromuscular blockage effect the acute hypoxic ventilatory response in patients with obstruktive sleep apnea syndrom before and after 3 months of continouse positive airway pressure treatment?
Adipose Derived Stem Cell Therapy for Autism
Dec 2011The intent of this clinical study is to answer the questions: - Is the proposed treatment safe - Is treatment effective in improving the disease pathology of patients with Autism.
Multicentre UK Study of the Acetylcholinesterase Inhibitor Donepezil in Early Dementia Associated with Parkinson's Disease (MUSTARDD-PD)
Dec 2011Is the cholinesterase inhibitor drug donepezil hydrochloride superior to placebo in improving cognitive function, neuropsychiatric burden and functional ability in people with Parkinson’s disease and mild dementia after 24 months of treatment?
A Double-blind, Placebo-controlled Study of Cariprazine (RGH-188) as Adjunctive Therapy In Major Depressive Disorder.
Dec 2011The objectives of this study are to evaluate the efficacy, safety, and tolerability of cariprazine adjunctive to ADT in patients with major depressive disorder who have an inadequate response to ADT.
Buspirone Therapy for Localized Epilepsy
Dec 2011The obective of this study is to test whether buspirone can reduce the frequency of seizures in people whose seizures seem to start from one part of the brain.
A Phase IIA, Multi centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Effect of 8 Weeks Treatment with Oral AZD3241 on Microglia Activation, as Measured by Positron Emission Tomography (PET), in Patients with Parkinson’s Disease
Dec 2011To evaluate the effect of 8 weeks treatment with AZD3241 on microglia activation as measured by [11C]PBR28 binding to TSPO.
A prospective, multinational, open-label, single-arm, explorative study to evaluate the tolerability and efficacy of Lacosamide when added to Levetiracetam with withdrawal of the concomitant sodium channel blocking antiepileptic drug in subjects with uncontrolled partial-onset seizures
Dec 2011The primary objective of this study is to assess the overall effectiveness of LCM (optimized within the range of 200mg/day to 600mg/day) when added to a stable dose of LEV (in the label range of 1000mg/day to 3000mg/day) with withdrawal of the concomitant SCB-AED in subjects with partial-onset seizures not adequately controlled on their dual LEV and SCB-AED regimen.
Correlation Between SV2A Expression in Tumour Tissue and Efficacy of Levetiracetam in Glioma Patients With Epilepsy
Dec 2011The purpose of this study is to investigate the correlation of SV2A expression in surgically removed tumour and tumour-surrounding tissue of glioma patients suffering from epilepsy with their clinical response to levetiracetam.
Correlation Between SV2A Expression in Tumour Tissue and Efficacy of Levetiracetam in Glioma Patients With Epilepsy
Dec 2011The purpose of this study is to investigate the correlation of SV2A expression in surgically removed tumour and tumour-surrounding tissue of glioma patients suffering from epilepsy with their clinical response to levetiracetam.
Comparison of Single versus Repeat Doses of AM-101 in the Treatment of Acute Inner Ear Tinnitus
Dec 2011Acute inner ear tinnitus following acute acustic trauma, acute otitis media, middle ear surgery, or inner ear barotrauma
Efficacy of RAD001/everolimus in Autism and NeuroPsychological deficits in children with TSC (RAPIT-trial)
Dec 2011The primary objective is to determine the effect of Everolimus on the cognition of children with TSC, measured by IQ.
Efficacy of agomelatine on sleep disturbance in Autism Spectrum Disorder (ASD)
Nov 2011To study the efficacy of agomelatine in improving the quantity and quality of sleep in patients with ASD as recorded by an integrated variable TAP.
Pilot, placebo-controlled, double-blind, randomized, parallel propofol effective in preventing refractory chronic migraine
Nov 2011To assess the analgesic efficacy of Diprivan ® infusion in the prevention of migraine refractory to medical therapy.
A Phase 3, Open-label, Multicentre, Protocol to Provide Access to Guanfacine Hydrochloride Extended Release for European Subjects with Attention-deficit/Hyperactivity Disorder (ADHD) who Participated in Study SPD503-315 or SPD503-316
Nov 2011The primary objective of this study is to evaluate the long term saftey of SPD503.
Treatment with Rotigotine of RLS patients with an insufficient response to dopamine agonist with intermediate half-life.
Nov 2011To investigate by m-SIT whether insufficient response to treatment with shorter-acting dopamine agonists is related to the presence of residual symptoms during the day in non-augmented RLS patients.
International Study to Predict Optimized Treatment - in Attention-Deficit and Hyperactivity Disorder
Nov 2011The primary objectives of the iSPOT-A trial are to use Brain Resource's standardized 'Integrative Neuroscience' test batteries to 1) Identify objective markers of ADHD compared with healthy controls, using cognitive, brain and genetic markers
A phase I/II, randomized, open-label, multi-centre study of BIBF1120 + reirradiation (R-RT) versus reirradiation in the treatment of patients with first or second progression of glioblastoma
Nov 2011Phase I - Maximal tolerated dose of BIBF1120 in combination reirradiation - Safety and tolerability of BIBF1120 in conjunction with radiotherapy - Pharmacokinetic studies in plasma and cerebrospinal fluid Phase II Primary objective: - 6 months rate of progression-free survival (PFS6)
Phase II pilot, prospective, open label, multicenter Clinical Trial, to evaluate the safety and efficacy of PF299804, a pan-HER irreversible inhibitor, in patients with recurrent glioblastoma with EGFR amplification or presence of EGFRvIII mutation
Nov 2011To assess progression-free survival (PFS) at six months (PFS6m) in patients with recurrent glioblastoma with EGFR amplification or presence of EGFRvIII mutation.
Efficacy of memantine in the treatment of fibromyalgia: an open, uncontrolled, exploratory 3-months follow-up study
Nov 2011Evaluate the efficacy of memantine in the reduction of glutamate brain levels in patients with fibromialgia
FLT-PET Imaging of Brain Tumors in Children
Oct 2011Brain tumors are the leading cause of death from solid tumors in children. Tumor imaging is important in the management of these tumors, but current imaging methods have limitations in providing the necessary information for optimal treatment of these patients. The goal of this study is to evaluate the potential utility of positron emission tomography (PET) with 3'-deoxy-3'-[F-18] fluorothymidine (18F-FLT) in the medical management of brain tumors in children.
Imaging Malignant Glioma With 68Ga-DOTATOC PET/CT
Oct 2011The purpose of this study is to characterize tumour uptake of somatostatin analog 68Ga-DOTATOC in patients with either primary or recurrent malignant glioma. The investigators hypothesis is that some primary and recurrent malignant gliomas overexpress SST2 receptor which can be imaged with 68Ga-DOTATOC PET/CT. The investigators also hypothesize that tumor uptake of 68Ga-DOTATOC correlates with immunohistochemically determined SST2 receptor status of the tumor specimen.
An Open-Label, Multicenter, Multinational Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Quality of Life as Reported by Subjects with Multiple Sclerosis
Oct 2011The primary objective of the study is to assess the effect of long-term treatment with prolonged-release fampridine 10 mg twice daily on the physical component scale (PCS) of the Short Form (36) Health Status Questionnaire (SF-36) as reported by treatment responders.
A multicenter, Double-blind 58 week Rollover Study to assess the Safety and Tolerability of BMS-820836 in Patients with Treatment Resistant Major Depression.
Oct 2011The purpose of this study is to evaluate the long-term safety and tolerability of BMS-820836 in patients with depression.
A Randomized, Double-Blind, Placebo- and Active-Controlled Phase 2 Dose-Ranging Study to Evaluate the Efficacy and Safety of ABT-126 in Subjects with Mild to Moderate Alzheimer's Disease
Oct 2011Evaluate the dose-response relationship with respect to the efficacy of symptomatic treatment and safety of three doses of ABT-126 in subjects with mild to moderate AD. The primary efficacy measure is the Alzheimer's Disease Assessment Scale – cognitive subscale (ADAS-Cog)
Short Course vs. Standard Course Radiotherapy in Elderly and/or Frail Patients With Glioblastoma Multiforme
Oct 2011This is a multi-centre prospective, non-inferiority trial. Patients will be randomized to two treatment groups in a 1:1 ratio and will be stratified by age, Karnofsky Performance Status and extent of the surgical resection. This study will assess the effect of a one-week radiotherapy regimen in comparison with a three-week radiotherapy regimen on the survival of elderly and/or frail patients with glioblastoma multiforme (Frail: ≥>50 years old and with a KPS of 50% or less50%-70%; Elderly and frail: ≥65 years and with a KPS of 50% - 70%; Elderly: ≥65 years and with a KPS of 80% - 100%).
Physical Exercise in Subjects With Juvenile Myoclonic Epilepsy (EFA)
Oct 2011This study is carried through as a randomized controlled trial which investigates the effect of participation in a 10-week cardio exercise program in people with Juvenile Myoclonic Epilepsy aged 15-50.
More Complete Removal of Malignant Brain Tumors by Fluorescence-Guided Surgery
Sep 2011The purpose of this study is to determine the safety and utility of 5-aminolevulinic acid (ALA) for identifying your tumor during surgery. 5-ALA is not FDA approved at this time. When the investigators remove the tumor from your brain, it is important that they remove all of the tumor and not remove parts of normal brain. Sometimes this can be difficult because the tumor can look like normal brain. In some brain tumors, 5-ALA can make the tumors glow red under blue light.
Tapentadol PR vs Oxycodon CR A pilotstudiy for a mechanism-orientated Therapy of peripheral chronic neuropathic pain syndrom
Sep 2011It shall be answered if Tapentadol PR compared to Oxycodon CR leads to a normalization of abnormal QST-Parameters (MPT, MPS, DMA and/or WUR with a Z-Value > 1,5 and/or a pathological side difference for these Parameters)
A multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson's disease associated pain
Sep 2011To demonstrate superiority of OXN PR compared to placebo with respect to analgesic efficacy in subjects with chronic severe pain associated with Parkinson's disease (PD), as assessed by averaged 24 hour pain scores collected for 7 days prior to the clinic visits.
Conventional Versus Virtual Reality Based Vestibular Rehabilitation
Sep 2011The aim of this study is to compare conventional vestibular rehabilitation with a force plate/virtual reality therapy based vestibular rehabilitation, using a universally available virtual reality system (Nintendo Wii Fit Plus®). In this study, consenting patients with a vestibular disorder will be assigned randomly to either a conventional treatment or a virtual reality based treatment that is customized to their individual problems. They will receive treatment for 8 weeks. The effects of treatment will be measured by state of the art computerized analysis of walking and balance. Questionnaires that obtain information about how severe their dizziness is will also be administered. The study will help therapists understand how inner ear problems affect walking and balance. It will also provide information on the optimum method of providing vestibular rehabilitation and thus improve patient care.
Evaluation of the efficacy, tolerability, and safety of 7 days of treatment with GRT6010 or pregabalin in comparison to placebo in subjects with peripheral neuropathic pain.
Sep 2011To explore the efficacy of GRT010 oral solution on spontaneous and evoked pain in subjects with persistent moderate to severe peripheral neuropathic pain due to post-herpetic neuralgia, post-operative neuropathic pain, or post-traumatic nerve injury
Investigating Cognitive Behavioral Therapy in Patients With Attention Deficit Hyperactivity Disorder (ADHD) and Substance Use Disorders
Sep 2011The purpose of this study is to determine if cognitive behavioral therapy is effective in treating ADHD symptoms in patients with substance use disorders and comorbid ADHD.
A randomized, double-blind, placebocontrolled, flexible-dose, parallel-group, Study of Lurasidone adjunctive to Lithium or Divalproex for the prevention of recurrence in subjects with bipolar I disorder
Aug 2011To evaluate the efficacy and safety of lurasidone (in combination with lithium or divalproex) for the maintenance treatment of bipolar I disorder in subjects with or without rapid cycling and/or psychotic features.
A Long-term, Phase 3, Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Oral OPC-34712 as Maintenance Treatment in Adults with Schizophrenia
Aug 2011To assess the long-term safety and tolerability of oral OPC-34712 as monotherapy in adults with schizophrenia. This trial is to be conducted on an outpatient basis.
A pilot clinical trial with the iron chelator Deferiprone in Parkinson's disease
Aug 2011To assess whether 6 month treatment with Deferiprone is well tolerated by PD patients and assess whether such treatment removes excess iron in the brain area affected in PD, the substantia nigra, as assessed by MRI.
Optimizing Antidepressant Treatment by Genotype-dependent Adjustment of Medication according to the the ABCB1 Gene
Aug 2011To evaluate the ABCB1-genotype dependent efficacy of a quick dose-escalation strategy within 21 days of treatment with approved antidepressants that are known substrates of the P-glycoprotein, an efflux pump of the blood-brain barrier expressed by ABCB1
A Long-term, Multicenter, Open-Label, Flexible Dose Continuation Study in Subjects Who Have Completed a Prior Lurasidone Study
Aug 2011To evaluate the long-term safety, tolerability and effectiveness of lurasidone in eligible subjects who have completed a prior lurasidone extension study.
A Preliminary Study of Intravenous Ketamine in Selective Serotonin Reuptake Inhibitor (SSRI)-Resistant Depression
Aug 2011To evaluate if IV ketamine treatment given weekly over 3 weeks relieves depressive symptoms in patients who have not responded to SSRI (Selective Serotoninn Reuptake Inhibitors) Antidepressants.
Towards Onset Prevention of COGnitive decline in adults with Down syndrome (the TOP-COG study)
Aug 2011The aims of the study are to gather the data needed to design a full-scale multi-centred RCT of oral simvastatin 40mg a day.
Efficacy and safety of 3 doses of S 38093 (2, 5 and 20 mg/day) versus placebo in patients with mild to moderate Alzheimer’s disease. A 24- week international, multi-centre, randomised, double-blind, placebo-controlled phase IIb study followed by a 24-week extension period
Jul 2011Main objective of the trial to assess the efficacy of S 38093 versus placebo after 24 weeks of treatment, on cognitive performance measured with the ADAS-Cog 11-items in patients with mild to moderate Alzheimer's disease.
A Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
Jun 2011The primary objective of the study is to determine whether armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood stabilizers for treatment of adults with major depression associated with bipolar I disorder. Efficacy will be assessed by the mean change from baseline in the total score from the 30-Item Inventory of Depressive Symptomatology–Clinician-Rated (IDS-C30).
Social Cognitive Development in Young Children With Autism
Jun 2011Through the development of a novel treatment targeting core Autism Spectrum Disorder (ASD) social deficits and studying the efficacy of this intervention, the investigators hope to provide a means for children with ASD to more effectively and efficiently process social information and enable them to more successfully engage in social interactions. Children between the ages of 24 and 36 months and their families may join.
Evaluation of the efficacy of Pregabalin for the treatment of evoked and non-evoked neuropathic pain at the level of the spinal cord injury during the early and late sub-acute phase of the spinal cord injury.
Jun 2011To evaluate the efficacy of Pregabalin for the treatment of evoked and non-evoked neuropathic pain at the level of the spinal cord injury.
Neurodegenerative Changes in Alzheimer’s Disease: Identifying potential effects of Victoza® on degenerative changes
Jun 2011To examine the effect of a 6 month treatment course with Victoza, a GLP-1 receptor agonist, on intracerebral amyloid aggregations determined by Pittsburgh Compound B PET-scans.
An open-label, single-arm, phase II, multicenter study to evaluate the efficacy of vemurafenib in metastatic melanoma patients with brain metastases
May 2011To evaluate the efficacy of vemurafenib using Best Overall Response Rate (BORR), as assessed by an Independent Review Committee (IRC) using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST, v1.1) in the brain of metastatic melanoma patients with previously untreated brain metastases
A multi-centre, randomized, double-blind, placebo-controlled, parallel-group, multiple oral dose study to assess the efficacy, safety and tolerability of AQW051 in reducing L-dopa induced dyskinesias in Parkinson’s patients with moderate to severe L-dopa induced dyskinesias
May 2011To assess the anti-dyskinetic efficacy of multiple doses of AQW051 in Parkinson’s patients with moderate to severe L-dopa induced dyskinesias using the modified Abnormal Involuntary Movement Scale (mAIMS). To assess the anti-parkinsonian effect of multiple doses of AQW051 in combination with L-dopa in Parkinson’s patients with moderate to severe L-dopa induced dyskinesias using the Unified Parkinson’s Disease Rating Scale (UPDRS) – part III. To assess the safety and tolerability of multiple doses of AQW051 in combination with Ldopa in Parkinson’s patients with moderate to severe L-dopa induced dyskinesias.
A Phase IIb/III, Double-Blind, Placebo-Controlled, Randomized Study Investigating the Safety, Tolerability and Efficacy of Flupirtine as Adjunct to Opioids When Administered to Cancer Subjects Who Are Experiencing Pain With Neuropathic Features
May 2011The primary objective of this study is to explore the overall analgesic efficacy of flupirtine administered in combination with opioids for a period of 5 weeks.
Epidemiologic Follow Up Study of Newly Diagnosed Epilepsy Among Seniors
May 2011The purpose of this proposed research is to identify individuals in southeastern Arizona aged 65 years and older who have new onset seizures (or newly diagnosed epilepsy) and monitor them for at least two years. In doing so the investigators will be able to describe the public health burden of this condition and to identify factors that predict clinical outcomes and health care needs in this population, using quantitative, administrative, and qualitative data. The aims of this proposed research are 1) to determine the two-year incidence of newly diagnosed epilepsy in the target population, 2) describe health care resource utilization of the target population using Medicare data, 3) validate the use of Medicare beneficiary data to estimate incidence of epilepsy, and 4) describe the burden of this condition in different ethnic groups.
A 6-month, open-label extension to a 40-week, randomized, double-blind, placebo-controlled, multicenter efficacy and safety study of Ritalin® LA in the treatment of adult patients with childhood-onset ADHD
May 2011To evaluate the long-term safety of Ritalin LA administered once daily for six months during open-label treatment in adults with ADHD.
Safety and Efficacy Study of Ladostigil in Mild to Moderate Probable Alzheimer's Disease
May 2011For many, Alzheimer's disease is the number one medical issue facing our aging society. It is a late onset neurodegenerative disease, frequently under diagnosed, that impairs memory and cognitive performance. There are no known treatments that can either prevent or reverse its progression. Consequently, there still remains a need to evaluate treatments which can better stabilize the symptoms of this disease. These symptoms frequently include decreased functional capacity and negative psychological attributes (e,g, depression, anxiety) in association with the memory and cognition deficits. This current study is being done to assess an investigational compound that has been designed to not only improved the cognitive status of affected patients but to also better manage all symptoms. Hence, the ultimate goal is to provide patients with an improved quality of life by slowing the progression of this neurodegenerative disease
Rasagiline treatment for Sleep disorders in Parkinson´s disease
Apr 2011Reduction of sleep disturbances
A randomized, placebo-controlled, double-blind, multi-center trial to assess the disease-modifying potential of transdermal nicotine in early Parkinson's disease in Germany and the USA (NIC-PD)
Apr 2011To demonstrate that transdermal nicotine treatment retards disease progression as measured by change in total (part I, II, III) UPDRS score between baseline and after 52 weeks of study treatment plus two more months wash out (60 weeks).
An open-label, Phase I/IIa, dose escalating study of 2B3-101 in patients with solid tumors with or without brain metastases.
Apr 2011To assess the safety and tolerability of 2B3-101 when administered intravenously (IV) in patients with solid tumors with our without brain metastases in order to determine the Maximum Tolerated Dose (MTD).
Prophylactic treatment of vestibular migraine with metoprolol: a double-blind, placebo-controlled trial
Apr 2011The primary objective is to demonstrate the superiority of Metoprolol Succinate treatment regarding the number of vertigo attacks and the number of headache attacks per month compared to placebo.
Toolkit for School Behavior Modification in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
Apr 2011The purpose of this study is to examine the efficacy of the ADHD-Toolkit (a toolkit for school behaviour modification in primary school children with ADHD-behaviours) in terms of general improvement in ADHD symptoms, specific targeted school-related problem behaviours, other disruptive behaviour disorder symptoms, teacher attitudes towards ADHD, teacher-child relationship and child self-esteem.
LY2216684 compared to Placebo as Adjunctive Therapy to SSRI in the Prevention of Symptom Re-emergence in Major Depressive Disorder
Mar 2011The aim of the study is to assess the time to re-emergence of depressive symptoms
Pharmacogenomics of Mood Stabilizer Response in Bipolar Disorder
Mar 2011The goal of this work is to identify genes associated with good response of bipolar patients to two commonly used mood stabilizing agents, lithium and valproate. 1. All patients will be started on lithium, then enter the maintenance phase where they will be followed for 2 years or until relapse. Those that fail lithium will be crossed over to valproic acid (VPA). Those that fail on VPA will be again crossed-over to a standardized treatment as usual (TAU) arm.
Double-Blind, Randomized, Historical Control Study of the Safety and Efficacy of Eslicarbazepine Acetate Monotherapy in Subjects with Partial Epilepsy Not Well Controlled by Current Antiepileptic Drugs
Feb 2011To evaluate the efficacy of eslicarbazepine acetate monotherapy at a dose of 1600 mg/day in subjects with partial epilepsy not well controlled by current antiepileptic drugs (AED), in comparison to a historical pseudo-placebo control group in accordance with the White Paper on Alternative Monotherapy Design in the Treatment of Epilepsy.
A multi-center, open-label, single-arm study to evaluate hormone and lipid levels in male subjects with partial onset seizures after a switch of treatment from carbamazepine as adjunctive treatment to levetiracetam to lacosamide as adjunctive treatment to levetiracetam.
Feb 2011The objective of this study is to evaluate the change in hormonal parameters and lipid parameters in serum after switching from Carbamazepine treatment to Lacosamide treatment as adjunctive therapy to Levetiracetam.
Electrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches
Feb 2011This investigation will gather information about a procedure called sphenopalatine ganglion (SPG) stimulation, and its appropriateness, safety, and efficacy as a treatment for those who suffer migraine headaches which may result in chronic severe disability. The SPG is a small collection of nerve cells in the head, and is located near the base of the nose on either side.
High-field structural and functional MRI to investigate the substrates of fatigue in multiple sclerosis and to monitor the effect of tailored treatments.Pharmacological substudy.
Feb 2011To evaluate the effects on brain activation patterns of drugs that are widely used in clinical practice for the treatment of fatigue in multiple sclerosis
A randomized, double-blind, placebo-controlled, parallel-group, multicenter, phase II study to evaluate the efficacy and safety of MABT5102A in patients with mild to moderate alzheimer’s disease
Jan 2011•To evaluate the efficacy of MABT5102A compared with placebo, when administered over 68 weeks to patients with mild to moderate AD, in inhibiting disease progression using the Alzheimer’s Disease Assessment Scale Cognitive Subscale (ADAS-Cog [12-item]) •To evaluate the safety and tolerability of MABT5102A compared with placebo when administered over 68 weeks to patients with mild to moderate AD
Pregabalin for anxiety comorbidity in patients with schizophrenia (PACS) - A Double-blinded Randomized Placebo Controlled Trial
Jan 2011To investigate the effect and tolerability of pregabalin for schizophrenic patients that suffer from comorbid anxiety.
Continued Efficacy and Safety Monitoring of Solanezumab, an Anti-Amyloid β Antibody in Patients with Alzheimer’s Disease
Dec 2010The primary objective of the study is to assess the safety of solanezumab in Alzheimer’s disease (AD) patients during 24 months of open-label treatment following completion of 18 months of treatment with solanezumab or placebo in a double-blind registration study (H8A-MC-LZAM [LZAM] or H8A-MC-LZAN [LZAN], “feeder studies”) through analysis of AEs, vital signs, laboratory evaluations, electrocardiograms (ECGs), and MRIs.
A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta.
Dec 2010Assess the effect of Teriflunomide in comparison to placebo on frequency of Multiple Sclerosis (MS) relapses in patients with relapsing forms of MS who are treated with interferon beta (IFN-β).
Evaluation of the Effect of Repetitive Transcranial Magnetic Stimulation in Pain Perception in Parkinson's Disease (rTMS)
Dec 2010This is a randomized, double blind cross-over study. In this study, subjective pain threshold (using thermal stimulation (Thermotest)).will be evaluated in 3 groups of subjects: healthy volunteers, painful Parkinson's patients and pain free Parkinson's disease patients.
Women With Epilepsy: Pregnancy Outcomes and Deliveries (WEPOD)
Dec 2010This is a three-center prospective case-control study to examine the patterns of fertility among women with epilepsy (WWE) compared to an age-matched group of women without epilepsy (WWoE).
An exploratory phase IIa study to evaluate the safety and immunological effects of intravenous interferonβ-1a (IFNβ-1a, Rebif®) therapy in the induction of tolerance to IFNβ in MS patients with neutralising antibodies (NAbs) to subcutaneous IFNβ-1a (Rebif® or Avonex®)
Dec 2010Perform a “proof-of-concept” phase IIa clinical trial to induce tolerance to IFNβ in subjects with NAbs to IFNβ-1a.
Optimization of Treatment and Management of Schizophrenia in Europe
Dec 2010(I) To test applicability of amisulpride as the first step in a treatment algorithm. (II) To test guideline recommendation that non-responders to an antipsychotic drug benefit from a switch to an antipsychotic with a different receptor binding profile. (III) To provide the acceptability and outcome data on the application of clozapine in non-responding patients within the first 10 weeks of their treatment initiation.
Behavioral effects and neural correlates of oxytocin on social attention
Dec 2010The overall aim of the proposed project is to investigate attentional processes in a social context and to modulate these processes by OXT. Based on the literature to date, it seems plausible that OXT modulates social cognitive processes such as the attention to emotional facial expressions differentially in ASD and neurotypical controls. Thus, the present study aims to investigate the modulatory role of OXT on attentional capture of social stimuli with varying emotional valence on the behavioral level in both typically developing adults as well as individuals with ASD. Participants will receive either OXT or a placebo in a randomized, double-blind group design.
A Clinical Trial of Exendin-4 for the Treatment of Alzheimer's Disease
Dec 2010To determine the safety and effectiveness of twice daily administration of Exendin-4 as a treatment for early-stage Alzheimer's disease or mild cognitive impairment.
Pioglitazone in Early Parkinson's Disease
Dec 2010This is a multi-center, double-blind, placebo controlled clinical trial of two dosages of oral pioglitazone (15 milligram(mg) and 45 milligram (mg)) for safety, tolerability, and futility.
Efficacy and safety of BIA 9-1067 in idiopathic Parkinson’s disease patients with “wearing-off” phenomenon treated with levodopa plus a dopa decarboxylase inhibitor (DDCI): a double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical study.
Nov 2010To investigate the efficacy of 2 different doses of BIA 9-1067 (25 mg and 50 mg), administered once a day, compared with placebo when administered with the existing treatment of L-DOPA plus a DDCI, in patients with PD and end-of-dose motor fluctuations.
Electrochemotherapy as a palliative treatment for brain metastases
Nov 2010Primary endpoint is safety of the trial treatment, electrochemotherapy for brain metastases. This is evaluated by regularly registrations of adverse events (serious adverse events and adverse events) using the CTCAE criteria version 4.0.
Oxcarbazepine for the treatment of chronic peripheral neuropathic pain: predictors of response - a randomised, double-blind, placebo-controlled clinical trial
Nov 2010To determine if oxcarbazepine is more efficacious for relief of periperal neuropathic pain in patients with irritable nociceptor pain phenotype than in patients without this phenotype.
A Single-Arm Open-Label Multi-Center Study to Determine the Specificity of Flutemetamol (18F) Injection for Excluding the Presence of Brain Amyloid in Healthy Young Adult Subjects Aged 18 to 40
Nov 2010To determine the overall specificity of Flutemetamol (18F) Injection for excluding the presence of brain amyloid based on the visual assessment of a positron emission tomography (PET) scan by independent blinded readers reviewing images from a population of healthy young adult subjects aged 18 to 40.
Sensory Attention Focused Exercise in Parkinson's Disease
Nov 2010The purpose of this study is 1.) to determine if sensory attention focused exercise is an effective management strategy for Parkinson's disease, and 2.) to identify if the benefits are a result of strength gains.
A randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of Ritalin® LA in adult patients with childhood-onset ADHD
Nov 2010Main objectives of the trial are; To confirm the clinically effective dose range of Ritalin LA in adults with childhood onset ADHD as measured by the change from Baseline to the end of a 9-week, fixed-dose treatment period in DSM-IV Attention-Deficit/Hyperactive Disorder Rating Scale (DSM-IV ADHD RS) total score. To evaluate improvement in functional impairment will be measured by the change from baseline in total score on the Sheehan Disability (SDS) is a self-rating scale designed to assess the functional impairment of patients with ADHD at the end of a 9-week fixed-dose treatment period. To evaluate the maintenance of effect of Ritalin LA in adults with childhood onset ADHD as measured by the percentage of Ritalin LA vs. placebo treatment failures at the end of a 6-month treatment withdrawal period. To evaluate the safety of Ritalin LA in adults with childhood onset ADHD as measured by the frequency of AEs, the results of laboratory tests, and the measurement of vital signs and ECGs.
Effects of methylphenidate on the development of the dopaminergic system in the brain
Nov 2010To report on the age-dependency of the effect(s) of MPH treatment on the outgrowth of the DA system using state-of-the-art Magnetic Resonance Imaging (MRI) techniques
Phase III Randomized Study of Adding Vincristine Sulfate, Topotecan Hydrochloride, and Cyclophosphamide to Standard Chemotherapy in Patients With Non-Metastatic Extracranial Ewing Sarcoma
Oct 2010The primary objective of this trial is to test the effect of the combination of vincristine, cyclophosphamide, and topotecan (VTC) added to the standard 5-drug chemotherapy interval-compressed backbone on event-free survival (EFS) and overall survival of children and young adults with Ewing sarcoma.
Alzheimer's Disease Neuroimaging Initiative 2 (ADNI2)
Oct 2010The purpose of this study is to build upon the information obtained in the original Alzheimer's Disease Neuroimaging Initiative (ADNI1) and ADNI-GO (Grand Opportunity; a study funded through an NIH grant under the American Recovery and Reinvestment Act), to examine how brain imaging technology can be used with other tests to measure the progression of mild cognitive impairment (MCI) and early Alzheimer's disease (AD). ADNI2 seeks to inform the neuroscience of AD. This information will aid in the early detection of AD, and in measuring the effectiveness of treatments in future clinical trials.
A two-phased, randomized, double blind, placebo-controlled study of ECP002A (Δ9-THC) to determine safety, tolerability and efficacy in Multiple Sclerosis patients suffering from spasticity and pain.
Oct 2010Evaluation of the efficacy of ECP002A (Δ9-THC) on spasticity in patients with MS
Impact of Levodopa vs. Rotigotine on stress hormones and NGF in patients with Parkinson's Disease: A randomised, placebo-controlled double-blind trial.
Oct 2010Main objective of the trial is the creation of "metabolic profiles" of two important pillars of therapy of Morbus Parkinson, namely Levodopa (+ Benserazide) and Rotigotin. The main focus is on the investigation of stress parameters and nerval growth factors, which are suspected of provoking neural lesions or may counteract such impairments.
A Phase 4, Open-label, Multicentre, 2-Year Safety Study of Lisdexamfetamine Dimesylate in Children and Adolescents Aged 6-17 Years with Attention-Deficit/Hyperactivity Disorder (ADHD)
Oct 2010To evaluate the long-term safety of SPD489 administered as a daily morning dose (30, 50, and 70mg) in the treatment of children and adolescents (6-17 years of age inclusive at the time of consent in this study or a previous SPD489 study (SPD489-317, SPD489-325, or SPD489-326) diagnosed with moderately to severely symptomatic ADHD.
Internet-CBT for Insomnia (IpsyInsomni)
Oct 2010This study includes two sub-trials.Both trials will include health economic data and analysis. For the longer follow-up periods (1 and 3 years), registers will be used to analyse consumption of sleep medication and antidepressants as well as general health care utilization.
Vercise Implantable Stimulator for Treating Parkinson's Disease (VANTAGE)
Oct 2010The purpose of this study is to document patient outcomes, including effectiveness, safety, and health economic data, for the Boston Scientific implantable deep brain stimulation (DBS) Vercise™ system for bilateral stimulation of the subthalamic nucleus (STN) in the treatment of moderate to severe idiopathic Parkinson's Disease (PD).
A Phase 3, Randomised, Double-blind, Multicentre, Parallel-group, Placebo- and Active-reference, Dose-optimisation Efficacy and Safety Study of Extended-release Guanfacine Hydrochloride in Children and Adolescents aged 6-17 years with Attention-Deficit/Hyperactivity Disorder
Oct 2010The primary efficacy analysis will be performed on the change from baseline for the ADHD-RS-IV total score at Visit 15 using Last-Observation-Carried Forward (LOCF) methodology, for all subjects randomised and receiving study drug. The mean change from baseline will be compared between treatments using an Analysis of Covariance (ANCOVA) model. The primary treatment comparison is SPD503 versus placebo. The ANCOVA model will include treatment group (the effect of interest), the corresponding baseline score (the covariate), and the blocking factors age group (6-12 years or 13-17 years) and country. The null hypothesis states that there is no difference between SPD503 and placebo, with the 2-sided alternative of a non-zero difference between groups.
Influence of Tapentadol on endogenous modulation of pain in chronic neuropathic pain patients and healthy volunteers
Oct 2010To study the effectivess of tepantadol vs morphien vs placebo on endogenous pain modulation
A 6-month prospective, multi-center, double-blind, placebo-controlled, randomized, adaptive-trial-design study to evaluate the safety and efficacy of 80mg b.i.d. ladostigil in patients with mild to moderate probable Alzheimer’s Disease with a 6-month open label follow-up period
Sep 2010To evaluate the efficacy of ladostigil (80mg b.i.d) administered for 26 weeks versus matched placebo and the safety of ladostigil (80mg b.i.d) following administration for up to 52 weeks - Alzheimer’s Disease Assessment Scale-Cognitive Subscale (Unmodified, 11 Item, total score = 70): (ADAS-Cog) - Safety evaluation: 26-week and 52-week assessment of safety and tolerability of ladostigil dosing.
A Multicenter, Double Blind, Double Dummy, Randomized, Positive Controlled Study Comparing The Efficacy And Safety Of Lacosamide (200 To 600mg/Day) To Controlled Release Carbamazepine (400 To 1200mg/Day), Used As Monotherapy In Subjects (≥16 Years) Newly Or Recently Diagnosed With Epilepsy And Experiencing Partial Onset Or Generalized Tonic Clonic Seizures
Sep 2010The objective of this study is to compare the efficacy and safety of Lacosamide (LCM) (200 to 600mg/day) to Carbamazepine Controlled release CBZ CR (400 to 1200mg/day) used as monotherapy for at least 1 year, efficacy being measured as a primary endpoint by 6 month seizure freedom, in newly or recently diagnosed epilepsy subjects. The study will employ a noninferiority design to show at least a similar benefit risk balance for LCM compared with CBZ CR, using 6-month seizure freedom as primary endpoint.
A Phase 3, Double-blind, Placebo-controlled, Multicentre, Randomised withdrawal, Long-term Maintenance of Efficacy and Safety Study of Extended-release Guanfacine Hydrochloride in Children and Adolescents Aged 6-17 With Attention deficit/Hyperactivity Disorder
Aug 2010The primary efficacy outcome for each subject is treatment failure during the double-blind randomised-withdrawal phase (Phase 2). The primary efficacy analysis will compare treatment failure rates between treatments (SPD503 and placebo) for all subjects who enter Phase 2 using a Cochran-Mantel-Haenszel (CMH) test stratified by age group and country. Subjects who discontinue for any reason during the randomised-withdrawal phase will be classed as treatment failures for the primary analysis. The null hypothesis states that there is no difference in treatment failure rate between SPD503 and placebo, with the 2-sided alternative of a non-zero difference between groups.
A Cognitive-Behaviour Therapy (CBT) Self-Management Approach for Insomnia in Chronic Pain: A Randomized Control Trial
Aug 2010This study will test the impact of a cognitive-behavioural self-management approach for the management of insomnia among patients with chronic pain.
A Phase II, multi-centre, randomised, double-blind, placebo-controlled, parallel group study to investigate the efficacy, safety and tolerability of Cogane™ (PYM50028), a novel, orally active neurotrophic factor inducer, in male and female subjects with early-stage Parkinson’s disease when administered once daily for 28 weeks
Aug 2010To determine whether PYM50028 exhibits clinical benefit in the treatment of subjects with early-stage Parkinson’s disease (PD), as assessed by the Unified Parkinson’s Disease Rating Scale score for Parts II and III combined (UPDRS II/III), compared with placebo.
A double-blind, parallel group, randomized, placebo controlled study of the efficacy of Circadin® 2mg in alleviating sleep disturbances in patients with mild to moderate Alzheimer Disease (AD) treated with Acetylcholinesterase (AChE) inhibitor.
Aug 2010To compare the effect of Circadin® to that of placebo, on sleep quality as assessed by the Daily Sleep Diary after 12 weeks of the double-blind treatment period.
Attention Deficit Hyperactivity Disorder (ADHD) and opioid maintenance therapy. A randomized, placebo-controlled study of the efficacy of atomoxetine for treating adult ADHD in patients receiving opioid maintenance therapy
Jul 2010To estimate the efficacy of atomoxetine when treating ADHD in patients with comorbid opioid dependence.
OCTUMI-4: Evaluation of Mirtazapine and Folic Acid for Schizophrenia: A randomised, double-blind, 2x2 factorial trial
Jul 2010Principal research question: Is mirtazapine as add-on therapy to antipsychotic treatment more effective than placebo for treatment of positive and negative symptoms of schizophrenia? Current treatments for schizophrenia, primarily antipsychotic drugs, are not fully effective. There is some evidence that treatment with mirtazapine plus an antipsychotic may be more effective than an antipsychotic alone ((Berk, Ichim & Brook 2001; Joffe et al. 2009; Zoccali et al. 2004)). OCTUMI-4 is designed to evaluate the effects of mirtazapine as add-on therapy to antipsychotic treatment in patients with schizophrenia who are currently experiencing active psychotic symptoms. OCTUMI-4 will be a double-blind placebo controlled randomised trial.
Genetic Contributions to Autism Spectrum Disorders
Jul 2010This study is working towards gaining a better understanding of the genetic and environmental factors involved in autism spectrum disorders (ASD), which includes autism, pervasive developmental disorder (PDD), and Asperger's syndrome. The investigators hope that information gained from this study will lead to new ways of diagnosing and treating ASDs.
A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664)
Jul 2010The primary efficacy objective of this trial is to evaluate the efficacy of a range of preladenant doses compared with placebo in subjects with early Parkinson's disease as measured by the sum of UPDRS Parts 2 and 3 scores. The primary safety objective of this trial is to evaluate the safety and tolerability of preladenant compared to placebo in subjects with early PD.
Study of Oculomotor Dysfunction Leading to Children Vertigo (VERVE)
Jun 2010The eye movements of vergence allow binocular vision whatever the viewing distance or the body movements are and the perception of depth. Vergence dysfunction can lead to erroneous visual sensation of movements. In our daily life using screens (computer, game boys..) is increasing and this approach heavily the ocular vergence and can lead to symptoms if oculomotor and accommodative systems are dysfunctioning (Ped. Neurology 2000). Not knowing this pathology lead to inappropriate and expensive prescription CT scan or NMR. To evaluate the vergence performances just evaluation in static condition is currently available in ophthalmology departments. The CNRS laboratory (IRIS, FRE 3154) adapted a technic of eye movement recording to study ocular vergence in dynamic condition.
A 15 week, randomized, double blind, parallel-group, placebo-controlled, flexible-dose, safety and efficacy study of pregabalin in adolescents (12-16 years old) with fibromyalgia
Jun 2010To evaluate the safety and efficacy of pregabalin (75-450 mg/day) compared with placebo in an adolescent fibromyalgia population.
A pilot study on the effect of ARA290 on pain and pain responses and retinal edema in patients with diabetes mellitus and neuropathic pain
Jun 2010To study the effectiveness of ARA290 in the treatment of pain in neuropathic pain patients
A Multicentre, Single-Arm, Open-Label Study Of The Repeated Administration Of QUTENZA For The Treatment Of Peripheral Neuropathic Pain
Jun 2010To assess the safety of repeated treatments of QUTENZA in subjects with peripheral neuropathic pain.
CONCERT PLUS: An Open-Label Extension of the CONCERT Protocol (DIM18) Evaluating Dimebon (Latrepirdine) in Patients with Alzheimer's Disease
Jun 2010To evaluate the long-term safety and tolerability of dimebon (latrepirdine) in Alzheimer’s disease (AD) patients who have completed 52 weeks of blinded treatment in the DIM18 (CONCERT) protocol.
Efficacy and Safety Study of Lomustine/Temozolomide Combination Therapy vs. Standard Therapy for Glioblastoma Patients
Jun 2010The prognosis of patients with newly diagnosed glioblastoma is dismal despite recent therapeutic improvements Using standard therapy with temozolomide (TMZ) and radiotherapy (60 Gy), the median overall survival time (mOS) is 14.6 months (Stupp et al., 2005). Since in a previous non-randomized bicentric phase II trial, primary combination chemotherapy with lomustine (CCNU) and TMZ was highly effective (mOS 23 months; UKT-03 trial; Herrlinger et al., 2006; Glas et al., 2009) the proposed trial further investigates the efficacy of CCNU/TMZ in a randomized multicenter phase III setting against standard therapy. In case the projected phase III trial confirms the phase II data, CCNU/TMZ combination would be significantly better than TMZ monotherapy and would thus be the new standard treatment for newly diagnosed GBM patients with a methylated MGMT promotor. Thus, this trial has the potential to profoundly change the standard therapy of this most aggressive brain tumor. Since in the previous trial only patients with a methylated MGMT (mMGMT) promoter had a benefit from CCNU/TMZ (mOS in the mMGMT group 34 months, in the non-mMGMT group 12.5 months; Glas et al., 2009) while patients with a non-methylated MGMT did not have any benefit, the trial is restricted to mMGMT patients.The CeTeG trial randomizes in a 1:1 fashion newly diagnosed GBM patients (18-70 years) for either standard TMZ therapy (concomitant and 6 courses à 4 weeks of adjuvant TMZ therapy) or experimental CCNU/TMZ therapy (6 courses à 6 weeks). Both arms include standard radiotherapy (RT) of the tumor site (30 x 2 Gy). Assuming that CCNU/TMZ therapy increases the median overall survival (mOS) from 48.9% (standard TMZ) to 70% (CCNU/TMZ; 75% in the previous phase II trial, Glas et al., 2009), 2 x 68 patients have to be accrued. Patients will be accrued over 24 months and each patient will be followed for at least 24 months adding up to a total minimal duration of the time from first patient in until the end of the follow-up time of 48 months. The primary endpoint is overall survival; secondary endpoints include progression-free survival, response rate, acute and late toxicity, and quality of life.
A 6-Month, Open-Label, Flexible-Dosage (150 to 200 mg/day) Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
Jun 2010The primary objective of this study is to evaluate the safety and tolerability of long term (6 months) armodafinil treatment as adjunctive therapy to mood-stabilizing medications in adults with bipolar I disorder whose most recent episode was a depressive episode.
Evaluation of an Intervention for Improving Community-based Pediatric Attention-Deficit Hyperactivity Disorder (ADHD) Care
Jun 2010Evaluation of an Intervention for Improving Community-based Pediatric ADHD Care
Effects Of Eslicarbazepine Acetate (Bia 2-093) On Cognitive Function In Children With Partial Onset Seizures: An Add-On, Double-Blind, Randomised, Placebo-Controlled, Parallel Group, Multicentre Clinical Trial
Jun 2010The primary study objective is to evaluate the effects of ESL on cognition in comparison with placebo as adjunctive therapy in children aged 6 to 16 years old with refractory partial-onset seizures (double blind 12 weeks)
Double blind, placebo-controlled randomized clinical trial to evaluate the efficacy and safety of a transtympanic treatment of tinnitus with caroverine
Jun 2010Caroverine infusions have been used successfully in Austria to treat cochlear-synaptic tinnitus. This treatment is very time consuming and needs a constant monitoring of the physician. This study will investigate the efficacy and safety of caroverine eardrops for transtympanic treatment of tinnitus. The aim is to ascertain whether the results of the proof of concept study using a 1,5 % solution can be reproduced.
An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson's Disease.
May 2010To evaluate the long-term safety and clinical utility of IPX066 in subjects with Parkinson´s disease (PD).
BIRN (Biomedical Informatics Research Network) Resources Facilitate the Personalization of Malignant Brain Tumor (CONDR)
May 2010The goal of this study is to create a comprehensive database of Magnetic Resonance Imaging (MRI) and of pathology for patients with brain tumors. Both standard, advanced, and research MRI components may be included, these will be analyzed in comparison with pathology results if/when a biopsy is obtained, and also used to predict/evaluate responses to therapy. This study will create a database of de-identified MRI images which include these techniques so that brain tumors can be studied over time (longitudinally) in an organized manner.
A Single Centre, Open-Label, Randomised Multi-Dose Study to Assess Changes in the Brain Metabolism of Juvenile ADHD Patients After Thirteen Weeks of Daily Intake of 4 g Superba Krill Oil or 4 g omega-3 Enriched Fish Oil
May 2010To evaluate changes in the brain metabolism of juvenile ADHD patients after thirteen weeks of daily doses of 4 g Superba krill oil or 4 g omega-3 enriched fish oil
ADHD - Voice Analysis, Vocal Acoustic Biomarkers in Attention Deficit Hyperactivity Disorder
Apr 2010The purpose of this study is to detect specific vocal acoustic patterns in the voice of attention deficit hyperactivity disorder (ADHD) patients.
Assessment of Sleep Complaints in Brain Tumor Survivors
Apr 2010Survivors of pediatric brain tumors are noted to have increased rates of excessive daytime sleepiness.However, very little data are available regarding the specific sleep disturbances of pediatric brain tumor survivors.Children ages 8 to 18 years of age who are active patients in the After Completion of Therapy Clinic and are at least 5 years from diagnosis and at least 2 years post treatment or observation only for a brain tumor will be targeted to assess the prevalence of sleep complaints.
Short- and long-term effects of oxytocin on empathy and social behaviour in autistic and antisocial male adults.
Apr 2010To investigate the effectiveness of 4-weeks treatment with intranasally adminsitered oxytocin twice a day versus placebo in improving social behaviour in patients with antisocial personality disorder and in those with autism spectrum disorder
The effectiveness of Parent-Child Interaction Therapy versus methylphenidate in preschool children with ADHD and disruptive behavior problems with insufficient improvement through Parent Management Training.
Mar 2010The primary aim of our study will be to investigate the effectiveness of PCIT in comparison with methylphenidate in children with ADHD and disruptive behavior problems aged 2;6 till 6 years who have not responded sufficiently to previously offered PMT.
Epilepsy Birth Control Registry (EBCR)
Mar 2010Despite the importance of birth control to women of reproductive age, there has been little formal investigation of the safety and effectiveness of birth control methods in women with epilepsy. To remedy this, doctors from Harvard and Columbia University Medical Schools have developed a website that offers a survey to help us gain more knowledge and some educational material that will be updated regularly to provide the latest information. The ultimate goal is to develop guidelines for the selection of safe and effective birth control methods and to make sure that the best forms of birth control become available to women with epilepsy in all communities of our society.
A Multi-Center, Open-Label Study To Evaluate The Tolerability, Safety And Efficacy Of Lacosamide (200 Mg - 400mg/Day) As Add-On Therapy For Patients With Partial Onset Epilepsy Using A Flexible Dose-Escalation Schedule And Individualized Maintenance Doses
Mar 2010The objective is to evaluate if a flexible dose escalation, up to 400mg/day (maximum recommended dose), or to a lower dose, clinically effective for an individual patient, improves lacosamide (Vimpat) tolerability.
Lidocaine patches in postoperative and posttraumatic neuropathic chronic skin pain - A prospective, randomized, double-blinded, placebo-controlled, parrallel, multicentre, investigator initiated study according to clinical guidelines
Mar 2010The primary study objective is to evaluate lidocaine patches analgesic efficacy in patients with chronic (present for more than 3 months) postoperative or posttraumatic neuropathic cutaneous pain (PNCCP) in comparison with the situation before therapy (baseline situation) and in comparison with the placebo patches.
IT-support for Home Training in Rehabilitation of Geriatric Patients With Vestibular Dysfunction
Mar 2010A solution to support the older vestibular rehabilitation process and to maintain the achieved level of functionality after the rehabilitation process is the computer-training program "Move It To Improve It" (MITII). Based on individual studies and tests therapists develop a personalized rehabilitation program permanently corrected, modified and adjusted. The system generates feedback to the therapists at hospital with information about the person's daily training and scores of individual exercises. The Web cam makes it possible to make video footage and pictures to be used in the feedback information. The system also establish direct communication between users and therapists. The web community provide the framework for a telerehabilitation system, which means that the hospital can service more users in the same period. HYPOTHESIS: Vestibular rehabilitation in 8 and 16 weeks with support of home training with MITII will result in improved function, balance and quality of life and reduction of experienced vertigo and dizziness handicap compared with 8 and 16 weeks of vestibular rehabilitation without IT support.
The Effects of Tetanus Vaccination on Mediators of Autoimmunity in Patients with Multiple Sclerosis
Mar 2010The primary endpoint will be measurement of the change in T-regulatory cells, by quantification of Foxp3 expression.
Repetitive Transcranial MAgnetic STimulation (rTMS) for MotoR and Mood Symptoms of Parkinson's Disease (MASTER-PD), a Multicenter Clinical Trial
Mar 2010The purpose of this study is to determine if repetitive transcranial magnetic stimulation (rTMS), a method of noninvasive brain stimulation) is effective in the treatment of the motor (movement) and mood symptoms due to Parkinson's disease (PD).
A Phase II, Multi-center, Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Pharmacodynamic Effect of Single and Multiple Oral Doses of AZD1446/ Placebo and a Single Dose of Donepezil on Quantified Electroencephalography (qEEG) and Event-Related Potentials (ERP) in Patients with Mild-to-Moderate Alzheimer's Disease
Feb 2010To evaluate the effect of single and multiple dosing of AZD1446 and a single dose of donepezil on Quantified electroencephalography (qEEG) and Event-related potentials (ERP) in patients with mild-to-moderate AD.
A Worldwide, Randomized, Double Blind, Placebo-Controlled, Parallel Group Clinical Trial to Evaluate the Safety and Efficacy of Rizatriptan for the Acute Treatment of Migraine in Children and Adolescents
Feb 20101. To evaluate the efficacy of rizatriptan compared to placebo in the treatment of acute migraine as measured by pain freedom at 2 hours in pediatric migraineurs between 12 and 17 years of age who have not, historically, achieved satisfactory response to treatment with NSAIDS or APAP. 2. To evaluate the safety and tolerability of rizatriptan in pediatric migraineurs between 12 and 17 years of age who have not, historically, achieved a satisfactory response to treatment with NSAIDS or APAP.
A Worldwide, Open Label, Clinical Trial to Examine the Long Term Safety and Tolerability of Rizatriptan in Pediatric Migraineurs for the Treatment of Migraine With or Without Aura
Feb 2010To evaluate the safety and tolerability of rizatriptan in the long term treatment of acute migraine in pediatric patients age 12-17 years.
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Long Term Safety Study of MK-4305 in Patients with Primary Insomnia
Jan 2010To evaluate the safety and tolerability of of MK-4305 for up to 12 months of treatment
Cognitive-Behavioural Therapy (CBT) for Insomnia Via Internet or Telehealth
Dec 2009This pilot study will compare the effectiveness of two brief (6 week) psychological interventions delivered to residents of rural Manitoba using Telehealth or an interactive Internet-based platform.
A Phase 3 Extension, Multicenter, Double-blind, Parallel-Group, Long-term Safety and Tolerability Trial of Bapineuzumab (AAB-001, ELN115727) in Subjects With Alzheimer Disease Who Are Apolipoprotein E ε4 Noncarriers and Participated in Study 3133K1-3000-WW
Nov 2009The primary objective of study 3133K1-3002-WW is to evaluate the long term safety and tolerability of intravenously administered bapineuzumab in subjects with Alzheimer Disease (AD) based on adverse events, scheduled vital signs, electrocardiogram parameters, clinical laboratory tests, brain MRI scans, physical and neurological examinations, and infusion site assessment. In addition, the studies will be continuously monitored by an independent safety monitoring committee.
Influence of a Dietary Supplement as Treatment of Migraine in Children and Adolescents
Nov 2009Migraine in children and adolescents can be associated with low serum levels of coenzyme q10, the key-enzyme of mitochondrial energy production.During migraine attacks inflammation is an important issue. Based on a double-blind placebo-controlled trial with coenzyme q10 in adults it is hypothesized that daily supplementation of coenzyme q10 as well as different antioxidative phytochemicals (from berries) and specific minerals and vitamins are able to reduce the "days with migraine" as primary parameter (open clinical trial).
Treating Insomnia & Nightmares After Trauma: Impact on Symptoms & Quality of Life
Nov 2009Exposure to trauma, especially when it manifests as Posttraumatic Stress Disorder (PTSD), results in numerous negative consequences for patients, families, and society. Some of the most frequent, disturbing, and treatment resistant symptoms of PTSD are nightmares and insomnia. This study will examine whether treatments specifically targeted at those sleep disorders can improve clinical outcomes and increase health-related quality of life in individuals recently exposed to war-related trauma. Hypotheses are that treating nightmares and insomnia will improve both nighttime and daytime symptoms of PTSD, as well as quality of life.
Clinical Trial of Donepezil Between the Patients With Alzheimer's Disease and Mixed Dementia
Oct 2009To compare the clinical efficacy of donepezil between patients with Alzheimer's disease and Mixed Dementia.
Lapatinib and Whole Brain Radiotherapy for patients with brain metastases from lung and breast tumors. A phase II study of the Hellenic Cooperative Oncology Group (HeCOG).
Oct 2009The main objective of the study is to measure the response rate in brain as assessed by volumetric analysis of brain MRI.
Prospective Randomized 12-Week Controlled Study Of Visual Field Change In Subjects With Partial Seizures Receiving Pregabalin Or Placebo
Oct 2009To evaluate visual fields in subjects with partial epilepsy receiving 12 weeks treatment of pregabalin compared to placebo.
Use of Duloxetine or Pregabalin in Monotherapy versus Combination Therapy of Both Drugs in Patients with Painful Diabetic Neuropathy “The COMBO - DN (COmbination vs Monotherapy of pregaBalin and dulOxetine in Diabetic Neuropathy) Study”
Sep 2009To evaluate whether treatment at standard doses with duloxetine (60 mg/day) in combination with pregabalin (300 mg/day) is superior to a maximal dose of duloxetine (120 mg/day) or pregabalin (600 mg/day) given as monotherapy, over an 8-week period, in patients with diabetic peripheral neuropathic pain, who don’t respond to a standard dose of either duloxetine or pregabalin after 8 weeks of initial treatment.
Phase III Randomized Study of Radiotherapy With Versus Without Temozolomide in Patients With Symptomatic or Progressive Low-Grade Gliomas
Sep 2009Primary Objectives: 1. To determine whether the addition of temozolomide to fractionated radiotherapy improves the progression-free survival (PFS) of patients with symptomatic or progressive low-grade gliomas. 2. To determine whether the addition of temozolomide to fractionated radiotherapy improves the median overall survival (OS) of these patients.
The effect of drugs used to reverse neuromuscular blockade on intra-cranial pressure
Sep 2009To determine whether sugammadex (Bridion) or neostigmine methylsulphate have any effect on intracranial pressure following elective neurosurgery
Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients
Sep 2009To evaluate the long-term safety and tolerability of safinamide (50-100 mg p.o., q. d.) in PD patients.
Effects of Rivastigmine Patch on Activities of Daily Living and Cognition in Patients With Severe Dementia of the Alzheimer's Type (ACTION)
Jul 2009This study will assess the efficacy of a higher dose of rivastigmine patch (15 cm2) compared to a lower dose of the rivastigmine patch (5 cm2), in patients with severe dementia of the Alzheimer's type.
Genetically determined brain abnormalities in Down’s Syndrome.- towards a treatment: A randomised, single-blind, placebo-controlled trial of lithium carbonate in Down’s Syndrome (DownsLit).
Jul 2009Our primary objective is to determine if brain myo-inositol concentration is significantly reduced in non-demented DS individuals by brief 4 week treatment with lithium carbonate at normal therapeutic doses with full monitoring of potential side effects in all participants.
A single arm, open-label trial assessing the effect of Capecitabine (Xeloda®) on progression-free survival rate at four months in breast cancer patients with CNS progression after whole brain radiotherapy
Jul 2009To evaluate the efficacy of capecitabine in terms of Progression Free Survival (PFS) rate at 4 months, reviewed by centralized independent expert, in treatment of brain metastases secondary to breast cancer in patients with CNS progression after whole brain radiotherapy (WBRT).
A Phase 3b, Double-blind, Randomised, Active-controlled, Parallel-group Study to Compare the Time to Response of Lisdexamfetamine Dimesylate to Atomoxetine Hydrochloride in Children and Adolescents aged 6-17 years with Attention Deficit/Hyperactivity Disorder (ADHD) Who Have Had an Inadequate Response to Methylphenidate Therapy.
Jul 2009The primary objective of this study is to compare the time to response of lisdexamfetamine dimesylate (SPD489) with that of atomoxetine hydrochloride (STRATTERA) in subjects who are judged by the Investigator to have had an inadequate response to methylphenidate (MPH) treatment where inadequate response includes, but is not limited to, the presence of some residual symptoms, inadequate duration of action and/or variability of symptom control, and/or Investigator feels that the subject may derive benefit from an alternative treatment to MPH therapy. The primary efficacy measure is time to response; where individual subject response is assessed using the Clinical Global Impressions – Global Improvement (CGI-I) Scale.
Radiation therapy and concurrent plus adjuvant Temsirolimus (CCI-779) versus chemo-irradiation with Temozolomide in newly diagnosed glioblastoma without methylation of the MGMT gene promoter – a randomized multicenter, open-label, Phase II study
Jul 2009The study’s primary objective is to document the activity profile of CCI-779 by the evaluation of OS12 in patients with newly diagnosed glioblastoma (GBM) without methylation of the MGMT gene promoter, treated with CCI-779 before and concomitantly to RT, followed by CCI-779 maintenance therapy.
Effect of NovoTTF-100A Together With Temozolomide in Newly Diagnosed Glioblastoma Multiforme (GBM)
Jun 2009The study is a prospective, randomly controlled pivotal trial, designed to test the efficacy and safety of a medical device, the NovoTTF-100A, as an adjuvant to the best standard of care in the treatment of newly diagnosed GBM patients. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields) to the region of the malignant tumor, by means of surface, insulated electrodes.
An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study
May 2009To investigate whether the effect of early-start rasagiline treatment (according to the ADAGIO study protocol) provided long term benefits over delayed-start, and to investigate the long-term effects of rasagiline in PD subjects who participated in the ADAGIO study and have continued on rasagiline treatment.
A randomised, REQUIP® IR-controlled, n-of-1, multiple crossover, pilot trial of the effect of REQUIP®CR on abnormal daytime somnolence in patients with Parkinson’s Disease
May 2009To compare the effect of REQUIP® CR and IR on the discomfort induced by global daytime somnolence in PD patients suffering from REQUIP® IR induced daytime somnolence.
Study of the Molecular Genetics of Menstrual Migraine
May 2009The aim of the study is to identify genes, genetic regions, and the effect of hormones on expression profiles in women with menstrual migraine compared to a control population with no personal or first-degree family history of migraine.
Why methylphenidate is not successful in cocaine-dependent ADHD patients: a SPECT study comparing DAT before and after methylphenidate treatment in ADHD patients with and without cocaine dependence
May 2009To determine why methylphenidate is not successful in cocaine-dependent ADHD patients, using SPECT to comparing DAT before and after methylphenidate treatment in ADHD patients with and without cocaine dependence
A superiority, randomized, open-label, multi-center study to compare the efficacy and safety of adjunctive zonisamide vs replacement with zonisamide of the last added antiepileptic drug in patients with partial onset seizures.
Apr 2009The primary objective of this study is to assess, in patients who respond to zonisamide added as third drug after failure of a two-drug combination therapy, the safety and efficacy of the triple therapy vs the double therapy.
Phase III Randomized Study of Radiotherapy Alone Versus Radiotherapy With Concurrent and Adjuvant Temozolomide Versus Temozolomide Alone in Patients With Newly Diagnosed 1p/19q Codeleted Anaplastic Glioma
Apr 2009The primary objective of this trial is to determine whether there is a survival advantage for patients with newly diagnosed 1p/19q codeleted anaplastic glioma who receive concurrent temozolomide and radiotherapy (RT) followed by adjuvant temozolomide over that observed in patients treated with RT alone (control).
Randomized, Controlled Study Evaluating CERE-110 in Subjects With Mild to Moderate Alzheimer's Disease
Apr 2009The purpose of this study is to evaluate the potential benefits of CERE-110 in the treatment of Alzheimer's disease. CERE-110 is an experimental drug that is designed to help nerve cells in the brain function better. CERE-110 uses a virus to transfer a gene that makes Nerve Growth Factor (NGF), a protein that may make nerve cells in the brain healthier and protect them from dying. The virus used in CERE-110 does not cause disease in people. CERE-110 has been carefully studied in laboratory animals and is in the early stages of being tested in people.
Efficacy of Transdermal Nicotine, on Motor Symptoms in Advanced Parkinson's Disease (NICOPARK2)
Mar 2009The main objective is to verify the correlation between UPDRS (score III) motor score and the administrated nicotine dose. This study will also allow the evaluation of nicotine neuroprotective effect.
CONNECTION PLUS: An Open-Label Extension of the CONNECTION Protocol (DIM14) Evaluating Oral Dimebon in Patients with Alzheimer’s Disease
Mar 2009To evaluate the long-term safety and tolerability of Dimebon in Alzheimer’s Disease (AD) patients who have successfully completed 26 weeks of blinded treatment in the CONNECTION protocol (DIM14).
Effet d’un traitement anti-glutamatergique sur les troubles de la marche avec freezing et sur l’attention dans la maladie de Parkinson: “freezing of gait and glutamate: FOGG-I”
Mar 2009analyse de la marche (longueur du pas) avec le système optoélectronique (Vicon®) sur les phases d’initiation et de marche lancée
Open-label, phase II, randomized, comparative, multicentre trial of concurrent Whole Brain Radiation Therapy (WBRT) and capecitabine (Xeloda®) followed by maintenance capecitabine compared with standard WBRT in breast cancer patients with newly diagnosed brain metastasis
Mar 2009To demonstrate the superiority of WBRT with concurrent capecitabine followed by maintenance capecitabine versus WBRT in best objective CNS response (CR + PR) in breast cancer patients with newly diagnoses CNS metastasis.
Efficacy and safety of Eslicarbazepine acetate as therapy in patients with fibromyalgia: a double blind, randomised, placebo controlled, parallel group, multicentre clinical trial
Mar 2009The primary objective of this study is to assess the efficacy of Eslicarbazepine Acetate as therapy in patients with fibromyalgia syndrome (FMS).
Evaluation de la captation d'un radioligand des transporteurs de la dopamine chez des sujets atteints de la maladie de Parkison et présentant ou non des douleurs en rapport avec cette pathologie.
Mar 2009L’objectif principal de ce travail est d’étudier la corrélation entre le degré de dénervation de la voie nigro striée objectivée par une scintigraphie cérébrale marquée au FP-CIT et le seuil subjectif de perception douloureuse évalué en thermotest chez des patients parkinsoniens placés en condition médicament OFF
Acupuncture for the Treatment of Insomnia
Mar 2009Insomnia is a common and disabling condition associated with psychiatric and medical comorbidities and often persists despite currently available treatments. Acupuncture has been reported to benefit individuals with insomnia and can decrease hyperarousal. This blinded RCT will investigate the impact of a standardized acupuncture protocol on insomnia, daytime symptoms, and hyperarousal.
Florida Center for Brain Tumor Research (FCBTR)
Dec 2008The purpose of this research study is to collect and store brain tumor tissue samples for future research. The samples will become part of the University of Florida Brain Tumor Tissue Bank/Florida Center for Brain Tumor Research. The goal is to find improved treatments and cures for brain tumors.
Efficacy of AM 101 in Patients with Acute Inner Ear Tinnitus: A Multi-Centre, Double-Blind, randomised, Placebo-Controlled, Multiple Dose, Group Comparison Phase II Study
Dec 2008The primary objective of the study is the evaluation of the therapeutic benefit of three repeated dose intratympanic AM-101 injections in comparison to placebo in the treatment of persistent acute inner ear tinnitus following acute acoustic trauma, sudden deafness or acute otitis media.
High-dose Chemotherapy With Autologous Stem Cell Rescue in Pediatric High-risk Brain Tumors
Nov 2008Reduced-dose Craniospinal Radiotherapy Followed by High-dose Chemotherapy and Autologous Stem Cell Rescue in Children with Newly Diagnosed High-risk Brain Tumor; High-dose Chemotherapy and Autologous Stem Cell Rescue in Infants and Young Children with Newly Diagnosed High-risk Brain Tumor To Avoid or Reduce Craniospinal Radiation; High-dose Chemotherapy and Autologous Stem Cell Rescue in Children with Recurrent Brain Tumor or Non-germinomatous Germ Cell Tumor with Inadequate Response to Conventional Treatment
Efficacy and safety of eplivanserin 5mg/day in insomnia characterized by sleep maintenance difficulties: a 6-week, randomized, double-blind, placebo-controlled, polysomnography study
Nov 2008To assess the efficacy of eplivanserin 5mg/day in comparison to placebo after 6 weeks of treatment on sleep maintenance of insomniac patients
A phase 2B, randomised, double-blind, placebo-controlled, parallel group, dose-ranging, multicentre study to investigate the efficacy, safety and tolerability of the mGluR5 negative allosteric modulator ADX10059 for the prevention of migraine
Nov 2008To evaluate the efficacy of three different doses of ADX10059 compared with placebo when administered daily for 12 weeks to prevent migraine in patients with a history of moderate or severe migraine
A multicenter phase II clinical trial assessing the efficacy of the combination of lapatinib and capecitabine in patients with non pretreated brain metastasis from HER2 positive breast cancer.
Oct 2008To assess the objective response rate by volumetric analysis of the combination lapatinib and capecitabine on brain metastasis as assessed by MRI, in metastatic HER2 positive breast cancer patients, prior to any brain radiotherapy.
A Phase IIa Randomized, Double-Blind, Parallel-Group, Placebo and Active-Controlled, Clinical Trial to Study the Efficacy and Safety of MK-0974 Co-administered with Ibuprofen or Acetaminophen in Patients with Migraine With or Without Aura
Oct 2008To evaluate the efficacy of MK-0974 co-administered with ibuprofen or acetaminophen/paracetamol compared to MK-0974 alone in the treatment of acute migraine, as measured by pain freedom at 2 hours post dose.
Motor function optimization in advanced Parkinson’s disease patients, combined with galantamine to prevent visual hallucinations.
Oct 2008To investigate if a stable optimal dose of galantamine can prevent an increase or emergence of VH after increase of L-dopa therapy.
An Open-Label, Long-Term Treatment Study to assess the Long-Term Safety and Tolerability and Efficacy of Neramexane in Patients with Subjective Tinnitus
Oct 2008The main purpose of the study is to evaluate the long-term safety and tolerability of daily doses of 50 or 75 mg (depending on fixed dose in the respective lead-in study) neramexane mesylate in the treatment of subjective tinnitus. The study will also investigate the durability of treatment effects (long-term efficacy)
A randomised, double blind, placebo-controlled study to evaluate the safety, tolerability and explore the efficacy of zonisamide as add-on therapy in elderly patients with refractory partial seizures.
Oct 2008To compare the effect of add-on treatment with zonisamide to that of placebo on cognition and sedation in an elderly population with refractory partial seizures.
Mindfulness-Based Approaches to Insomnia
Oct 2008The overall goal of this project is to evaluate the evidence for the efficacy of two mindfulness-based interventions, mindfulness-based therapy for insomnia (MBT-I) and mindfulness-based stress reduction (MBSR), for reducing arousal and improving sleep among individuals with psychophysiological insomnia. Specific Aim 1: To obtain evidence for the relative effects of MBT-I and MBSR compared to a delayed-treatment control condition followed by behavior therapy for insomnia (BT-I) on arousal levels. It is hypothesized that MBSR and MBT-I will be superior to the control condition at reducing arousal levels. Specific Aim 2: To obtain evidence for the relative effects of MBT-I, MBSR, and the delayed-treatment control on sleep. It is hypothesized that MBT-I will be superior to the MBSR and control conditions at improving sleep parameters. Specific Aim 3: To investigate the relationship between measures of arousal (self-report and objective measures) and sleep (self-report and objective measures) to enhance the understanding of the role of arousal in psychophysiological insomnia.
Multi center, double blind, randomized, placebo controlled, active reference, parallel group polysomnography study to assess the efficacy and safety of a 16 day oral administration of ACT 078573 in adult subjects with chronic primary insomnia.
Aug 2008To demonstrate an effect of ACT-078573 at 200 mg at treatment start and at 16 days on a set of objective sleep-maintenance endpoints and over 2 weeks on a subjective sleep-maintenance endpoint.
Neurocognitive testing in children with ADHD
Jun 2008Main objectives of the trial are; 1. to measure the effects of methylphenidate using the Neurocart test battery, to establish if these effects can be differentiated from placebo and to determine circadian variation in effect, 2. to describe the drug concentrations of methylphenidate in saliva, 3. to describe the PK/PD relationship using the obtained saliva samples, 4. to describe cardiovascular effects of methylphenidate (blood pressure and heart rate); 5. to evaluate clinical treatment effect during the trial, 6. to evaluate how children have experienced trial participation.
Pharmacokinetic-pharmacodynamic modeling of S(+)-ketamine in fibromyalgia
Jun 2008The main objectives of this study are : pain reduction of fibromyalgia related pain and improvement of quality of life
Residual effects of zopiclone 7.5 mg on cognition and driving performance in insomnia patients chronically using hypnotics
Jun 2008To determine whether the residual effects of zopiclone 7.5 mg on driving performance in patients complaining of insomnia and who chronically use hypnotics differ from the effects in insomnia patients who do not regularly use hypnotics and from matched healthy controls.
An open-label, multinational, multicenter, follow-up study to evaluate the long-term safety and efficacy of brivaracetam, used at a flexible dose up to a maximum of 200 mg/day, in subjects aged 16 years or older suffering from epilepsy.
Jun 2008To evaluate the long-term safety and tolerability of brivaracetam at individualized doses with a maximum of 200 mg/day in subjects suffering from epilepsy.
A randomised, double-blind, placebo- and active comparator-controlled, five parallel groups study to investigate the efficacy and safety of BI 44370 TA (50 mg, 200 mg, and 400 mg) administered orally once during an acute migraine attack of moderate or severe intensity
Jun 2008The primary objective is to achieve a pain free response, defined as reduction of severe or moderate headache to no headache, 2 hours after dosing with BI 44370 TA in comparison with placebo, in patients with an acute migraine attack of moderate or severe intensity.
Effet de la Nicotine transdermique sur les symptomes moteurs de la maladie de Parkinson avancée (une administration quotidienne) .Etude contrôlée, randomisée, en deux groupes parallèles et en simple insu sur 40 patients.
Jun 2008Comparaison du score moteur de l'échelle UPDRS (score III) mesuré en état "defined OFF " à la dose maximale de nicotine administrée après 20 semaines de traitement en comparaison au groupe témoin.
A Phase III, Open-Label, Extension, Multicentre, Safety Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17 with Attention-Deficit/Hyperactivity Disorder (ADHD)
May 2008The primary objective of this study is to evaluate the long-term safety of LDX administered as a daily morning dose (30, 50, and 70mg/day) in the treatment of children and adolescents (6 -17 years of age inclusive at the time of consent for the antecedent study, SPD489-325) diagnosed with moderately symptomatic ADHD. The evaluation of safety will be based on the occurrence of treatment-emergent adverse events (TEAEs), specific evaluation of blood pressure and pulse, electrocardiogram (ECG) results, clinical laboratory test results, and physical examination findings.
A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group Multiple Attacks Study to Compare the Efficacy and Safety of Oral MK-0974 With Placebo for the Acute Treatment of Migraine With or Without Aura
May 2008To evaluate the efficacy and safety of MK-0974 compared to placebo in the treatment of acute migraine / To evaluate the safety and the consistency of efficacy of MK-0974 across multiple migraine attacks.
A phase IV randomised, double-blind, placebo-controlled, dose titration trial with pramipexole (Sifrol®, Mirapexin®) 0.125-0.75 mg/day per os to investigate the long-term efficacy, safety and tolerability in patients with idiopathic moderate to severe Restless Legs Syndrome for 26 weeks
Apr 2008The primary objective of the current study will be the evaluation of long-term efficacy of a 26-weeks treatment with pramipexole in patients with idiopathic moderate to severe Restless Legs Syndrome in comparison to placebo.
A randomised, double-blind, double-dummy, oral donepezil controlled study on the safety and efficacy of repeated monthly subcutaneaous injections of a sustained-release implant of ZT-1 in patients with moderate Alzheimer’s Disease (AD)
Feb 2008The main objectives of this study are to assess the efficacy of the ZT-1 implant in improving cognitive function, behavioural and overall outcomes, compared to oral daily doses of donepezil and to assess the safety of the ZT-1 implant, compared to oral daily doses of donepezil.
Behavioral Insomnia Therapy For Those With Insomnia and Depression
Feb 2008This study is a randomized clinical trial to test the efficacy of Cognitive-Behavioral Insomnia Therapy when used in isolation or in combination with antidepressant medication (escitalopram) among patients with Major depressive disorder and insomnia.
Adjunctive Donepezil Therapy and Genetic Risk Factors of Cognitive Dysfunction in Brain Tumor Survivors
Jan 2008A significant number of brain tumor patients who received radiation or chemotherapy have thinking problems as a result of their treatment. The purpose of this study is to find out if treatment with Aricept (donepezil) may improve some aspects of thinking abilities in patients with brain tumors who received radiation or chemotherapy. This research will also study whether persons having particular genes for a blood-borne substance called apolipoprotein E (APOE) are more likely to have thinking problems after radiation or chemotherapy treatment for their brain tumors. The findings of this study will help us find out whether Aricept can improve thinking abilities after cancer treatment, and whether some of the thinking difficulties may be in part related to having certain genes.
Risk Factors for Adult-Onset Brain Tumors
Jan 2008This is a case-control investigation. Persons affected with a brain tumor are compared to unaffected persons on previous medical history, diet and other factors. Those enrolled in the study will participate in an interview on general background, diet, medical history and lifestyle, and will provide a sample of DNA, clippings of your toenails, and a tap water sample from your home. All procedures are performed in the clinic or through the mail.
A 6-month, double-blind, randomized, placebo-controlled, parallel group outpatient trial, investigating the efficacy and safety of Org 50081 in adult patients with chronic primary insomnia.
Dec 2007To demonstrate the long-term efficacy of treatment with Org 50081, as compared to placebo, on sleep maintenance in patients with chronic primary insomnia as measured by the subjective Total Sleep Time. Primary efficacy endpoint is the average of subjective Total Sleep Time (TST) during month 4 to month 6, as recorded daily in the sleep diary.
Evaluation of the effect of 6 months treatment with DC158AM on fatigue in patients with Parkinson’s disease. Multicentre, randomised, double-blind, placebo-controlled study in parallel groups.
Dec 2007To evaluate the efficacy of 6 months treatment with DC158AM on fatigue in patients with Parkinson’s disease.
Influence of methylphenidate on sleep and circadian rhythm in children with Attention-Deficit/Hyperactivity Disorder (ADHD)
Nov 2007Determine the influence of methylphenidate treatment on sleep-wake rhythm and endogenous melatonin rhythm in children with ADHD.
Open Label Study of the Effect of Daily Treatment with MPC-7869 in Subjects with Dementia of the Alzheimer’s Type
Nov 2007Main objective of the trial is to evaluate the safety of long term treatment with MPC-7869
A double-blind placebo controlled study of 1g, 2g and 4g V0251 efficacy and tolerance in vestibular neuritis.
Oct 2007To determine efficacy of 3 doses versus placebo of L-acetylleucine within 4 days of intravenous administration in patient hospitalised for vestibular neuritis.
A Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of ABT-894 versus Placebo in Subjects with Diabetic Neuropathic Pain
Oct 2007To compare the analgesic efficacy and the safety of ABT-894 (6 mg tablets) administered twice daily (BID) to placebo in the treatment of diabetic neuropathic pain (DNP).
A Non-Randomized, Within Subject Placebo-Controlled Exploratory Study of the Effects of JNJ-26489112 on the Photic Induced Paroxysmal EEG Response in Subjects with Photosensitive Epilepsy
Sep 2007To determine oral doses of JNJ-26489112 that result in complete suppression or reduction of IPS induced photoparoxysmal-EEG response, a marker of antiepileptic activity. To assess the safety, tolerability, pharmacokinetics and pharmacokinetic/pharmacodynamic relationship of JNJ-26489112 in subjects with photosensitive epilepsy.
A double-blind, randomised, placebo-controlled, multi-centre study to assess the efficacy and safety of adjunctive zonisamide in paediatric partial onset seizures
Sep 2007To assess the efficacy of zonisamide in paediatric epilepsy subjects with partial onset seizures treated with one or two other AEDs.
A 52-week, multi-center, randomized, double-blind, placebo-controlled, parallel group study in patients with mild Alzheimer’s Disease (AD) to investigate the safety and tolerability of repeated subcutaneous injections of CAD106
Sep 2007To evaluate the safety and tolerability of repeated subcutaneous (s.c.) injections of 150μg CAD106 in patients with mild AD over the 52 weeks of the study.
A Long-Term, Open-Label Safety and Efficacy Study of Xyrem (sodium oxybate) in Subjects with Fibromyalgia
Aug 2007The primary objective of this study is to assess the safety of Xyrem (sodium oxybate) in long term use (up to 38 weeks) in subjects completing a double-blind controlled trial of Xyrem for the treatment of fibromyalgia.
The effect of beta-adrenergic receptor blockade on sympathetic activity and coagulation in patients with heart failure (BACH-F study)
Aug 2007To analyse whether the hypercoagulable response to sympathetic activation in heart failure patients is reduced more effectively by carvedilol than metoprolol and whether this response differs from that in healthy controls. To analyse whether the hypercoagulable response to sympathetic activation in heart failure patients and in healthy controls is determined by the beta2-adrenergic genotype.
A Prospective Study to Determine the Adverse Drug Reactions Profile of Anticonvulsants in Children
Jul 2007To prospectively determine the nature and rate of adverse drug reactions, or side effects, in children on anticonvulsants.
Effects of insomnia and chronic use of hypnotics on driving performance
Jun 2007The primary objective of the study is to compare over-the-road driving performance of treated and untreated patients complaining of insomnia, with that of healthy controls matched for age, gender and annual mileage.
Radiation Therapy With or Without Temozolomide in Treating Older Patients With Newly Diagnosed Glioblastoma Multiforme
Jun 2007This randomized phase III trial is studying radiation therapy and temozolomide to see how well they work compared with radiation therapy alone in treating patients with newly diagnosed glioblastoma multiforme.
Monitoring des états cognitifs chez des sujets volontaires sains, sur 2 périodes, l'une avant et après administration d'une dose unique de Zolpidem, l'autre sans administration de traitement
Apr 2007It's a phase II study performed on healthy volonteers. Zolpidem (DCI) will be administered to the volunteers in order to inducing a drowsiness and a hypoattentiveness. Zolpidem is indicated in the treatment of occasional and transitory insomnia.
Efficacy and safety of 2 mg/day M100907 on Sleep Maintenance Insomnia: a 6-week, multicenter, randomized, double-blind, placebo-controlled Polysomnographic study
Apr 2007Efficacy of M100907 - 2 mg/day in comparison to placebo for Sleep Maintenance Insomnia using change from baseline at 6 weeks of treatment of night polysomnography (NPSG) wake time after sleep onset (WASO).
Correlation Between SV2A Expression in Tumour Tissue and Efficacy of Levetiracetam in Glioma Patients With Epilepsy
Mar 2007The purpose of this study is to investigate the correlation of SV2A expression in surgically removed tumour and tumour-surrounding tissue of glioma patients suffering from epilepsy with their clinical response to levetiracetam.
A multicenter, multiple dose, double-blind, randomized, placebo-controlled, parallel group study of the safety and efficacy of AGN 203818 in female patients with fibromyalgia syndrome.
Mar 2007To evaluate the safety and efficacy of AGN 203818 oral capsules administered twice-daily as compared with placebo in female patients with fibromyalgia syndrome.
A double-blind, cross-over patient preference study of frovatriptan versus rizatriptan for the acute treatment of migraine
Mar 2007The primary objective of this study is to evaluate the subjective patient’s preference for either study medication after having tested both of them on a number of between 1 and 3 attacks of migraine in a maximum period of 3 months.
A Phase II Study of Lapatinib plus Topotecan or Lapatinib plus Capecitabine in the Treatment of Recurrent Brain Metastases from ErbB2-Positive Breast Cancer Following Cranial Radiotherapy
Mar 2007In each of the two study arms (lapatinib plus topotecan or lapatinib plus capecitabine), the primary objective is to determine the CNS objective response rates in subjects with progressive brain metastases from ErbB2-overexpressing breast cancer. A CNS objective response is defined as either a Complete Response (CR) or Partial Response (PR), as assessed by volumetric analysis of brain magnetic resonance imaging (MRI), provided there is no progression of systemic disease outside of the CNS or increasing steroid requirements.
An Open-Label Extension of the Phase III Study CL-758010 with Alzhemed™ in Patients with Alzheimer’s Disease.
Mar 2007The primary objective of this open-label study is to evaluate the long-term safety of Alzhemed™ in patients with Alzheimer’s Disease (AD).
A Randomized, Controlled, Open-Label Study of the Long-Term Impact on Functioning using Atomoxetine Hydrochloride Compared to Other Early Standard Care in the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Treatment-Naïve Children and Adolescents. (ADHD-LIFE Study)
Feb 2007The primary objective is to test the hypothesis that atomoxetine given at individually titrated doses for 6 months is superior to other early standard therapy in improving quality of life as measured by the mean change in the achievement domain of the Child Health and Illness Profile – Child Edition, Parent Report Form (CHIP-CE PRF), in pharmacologically naïve children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD).
Gliogene: Brain Tumor Linkage Study
Jan 2007The goal of this research study is to investigate the role of genes that may point to a higher risk of developing a glioma. Researchers will use new gene mapping techniques to study how high-risk factors are passed on through a family's genes and increase the risk of developing gliomas. We propose an international multi-center, multidisciplinary study consortium, GLIOGENE, to identify susceptibility genes in high-risk familial brain tumor pedigrees using the most sophisticated genetic analysis methods available.
A single center, randomized, open-label, comparative study to assess efficacy and safety of piracetam 4.8g/d administered for 6 months as adjuvant to standard vestibular rehabilitation (VR) therapy utilizing Cooksey Cawthorne exercises to adults suffering from moderate to severe vertigo of peripheral origin lasting for at least 3 months.
Dec 2006To ascertain whether adding piracetam to vestibular rehabilitation (VR) contributes to the improvement of abnormal neuro-otological findings including ENG at the end of the 180-day treatment period compared to baseline
A european phase III, multicentre, double-blind, randomised, monotherapy, 12-month study of Milnacipran for the treatment of the Fibromyalgia Syndrome
Oct 2006To assess the long-term safety of milnacipran used for the treatment of FMS at doses of 100, 150 and 200 mg daily.
A double-blind, placebo-controlled, parallel-group study, to investigate the efficacy, safety and tolerability of the MGLUR5 negative allosteric modulator ADX10059 in the acute treatment of migraine
Sep 2006The primary study objective is to evaluate the efficacy of oral ADX10059 in the acute treatment of moderate or severe migraine headache pain.
Omega-3 Fatty Acids Supplementation for Adolescent Boys with Attention Deficit Hyperactivity Disorder : a double-blind, randomized controlled trial
Apr 2006ADHD symptoms are often carried through to the adolescent period and long-term intervention is often needed. Patients and their parents often choose alternative treatments for ADHD. Omega-3 fatty acids supplementation is one popular alternative treatment, and relatively safe, but the effectiveness has not been assessed enough . This study aims to evaluate whether EFA supplementation improves ADHD symptoms in ADHD male adolescents.
Safety Study of Intracerebral Topotecan for Recurrent Brain Tumors
Mar 2006This study will evaluate the safety and efficacy of a chemotherapeutic drug (topotecan) as it is given directly into brain tumors by a delivery technique called convection-enhanced delivery. This drug has been used for different types of cancer, but in this study it will be given by an experimental delivery technique designed to maximize the amount of drug delivered to the brain tumor and minimize the side effects in other parts of the body. This study will also evaluate advanced MR imaging techniques. The study will assess quality of life parameters throughout the follow-up period.
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