Results from Phase III LMS-003 trial of Firdapse in Lambert-Eaton Myasthenic Syndrome published in Journal of Clinical Neuromuscular Disease.- Catalyst Pharma
Catalyst Pharmaceuticals announced the online publication in the Journal of Clinical Neuromuscular Disease of the results of its second Phase III clinical trial (LMS-003) evaluating Firdapse (amifampridine phosphate) for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS). The positive topline results from this trial were previously announced, but the full results of safety, efficacy, and other clinical data are now available online. The LMS-003 trial was a randomized, double-blind, placebo-controlled design.
Both co-primary endpoints were met with statistical significance (QMG score: p=0.0004 and Subject Global Impression Score: p=0.0003). This was further supported by similar success with other endpoints (Triple Timed Up and Go walk test and the Clinical Global Impression of Improvement). The study provided statistically and clinically significant evidence that Firdapse was safe and effective in treating LEMS patients.
See: "Amifampridine Phosphate (Firdapse) Is Effective in a Confirmatory Phase 3 Clinical Trial in LEMS" Shieh, Perry et al. Journal of Clinical Neuromuscular Disease: March 2019 - Volume 20 - Issue 3 - p 111�119 doi: 10.1097/CND.0000000000000239
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
1 mins