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Trials & Filings

Alcobra Enrolls Last PI-ADHD Patient

Results expected by December 2013

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Alcobra Ltd. has successfully enrolled the 36th and final patient in a placebo-controlled Phase II study designed to compare the efficacy of varied dosage levels of MG01CI to treat and improve cognitive dysfunctions in adult subjects with Predominantly Inattentive Attention Deficit/Hyperactivity Disorder (PI-ADHD). The last patient visit is scheduled for November 26, 2013 and the data is expected to be announced during the week of December 16, 2013.

The study is evaluating 700mg and 1,400mg doses, which were found to be most effective in previous Alcobra studies. The data from the study is expected to confirm and consolidate previous observations about MG01CI, including: the significant effect size seen in PI-ADHD patients; the benefits on executive functions (beyond core deficits of ADHD) such as spatial and working memory, visual information processing, reaction time and inhibitory control; and the rapid onset of the drug (as compared to other non-stimulants ADHD drugs that take several weeks).

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