BioCentury
ARTICLE | Clinical News

Metadoxine: Phase IIb data

December 23, 2013 8:00 AM UTC

A double-blind, crossover, Israeli Phase IIb trial in 36 adults with predominantly inattentive ADHD showed that a single dose of 1,400 mg MG01CI met the primary endpoint of improving mean TOVA ADHD scores from baseline to 4 hours post-dose vs. placebo (mean change of 2 points compared to placebo, p=0.009). High-dose MG01CI also significantly improved the mean TOVA ADHD subscore of reaction time variability by 7.9 points from baseline to 4 hours post-dose compared to placebo (p=0.022). Additionally, the mean change in TOVA ADHD score from baseline to 4 hours post-dose was 1.8 points greater in patients receiving high-dose MG01CI compared to patients receiving a single 700 mg dose of MG01CI (p=0.032).

Alcobra said the primary endpoint analysis did not include the 700 mg dose. In a conference call to discuss its 3Q13 earnings, Alcobra said it included the lower dose in the trial to fulfill an FDA requirement to evaluate the minimally effective dose, but the company does not plan to include the lower dose in its Phase III program. There were no serious adverse events or meaningful differences in adverse event profiles between MG01CI and placebo. The trial consisted of a screening period of up to 1 week, a 3-week double-blind treatment period and a 1-week safety follow-up period. Alcobra plans to start a U.S. Phase III trial with MG01CI to treat ADHD in early 2014. ...