Programme cancelled for MG01CI (metadoxine extended release) in treatment of attention deficit hyperactivity disorder- Alcobra
Alcobra says that top-line results from the Phase III MEASURE trial of MG01CI (metadoxine extended release) failed to show a statically significant difference between placebo in patients with attention Deficit Hyperactivity Disorder (ADHD). This was measured in the change from baseline of the investigator rating of the Conners' Adult ADHD Rating Scales (CAARS). As a result, the company has announced that it will this end its development in this indication.
Comment: In September Alcobra announced that it has received verbal notice from the Division of Psychiatry Products of the FDA that a full clinical hold has been placed on its Investigational New Drug (IND) applications for MDX in ADHD.
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