Alcobra Adult ADHD Drug Posts Good Results

Alcobra has posted highly statistically significant positive results from a Phase IIb clinical trial with MG01CI (Metadoxine extended-release) in adults with Predominantly Inattentive Attention Deficit Hyperactivity Disorder (PI-ADHD).

The trial was a randomized, double-blind, placebo-controlled, cross-over single center study that enrolled 36 adult subjects with PI-ADHD at Geha Mental Health Center in Petach Tikva, Israel. Eligible subjects were randomly assigned in a 1:1:1 ratio to one of three treatment sequences that varied the order of investigational product administration. In each treatment sequence, subjects received a single administration, approximately one week apart and in different orders, of MG01CI 1,400 mg, MG01CI 700 mg and placebo. The primary outcome was the change from baseline of the Test of Variables of Attention (TOVA) ADHD score. The TOVA is a computerized continuous performance test that provides information about an individual’s sustained attention, speed and consistency of responding, and behavioral self-regulation.

In an intent-to-treat analysis of the primary endpoint, the study demonstrated a statistically significant change from baseline for MG01CI 1,400 mg compared with placebo on the TOVA ADHD score. The study also demonstrated a statistically significant change from baseline for MG01CI 1,400 mg compared with placebo on the TOVA sub-score of reaction time variability, as well as a statistically significant change from baseline for MG01CI 1,400 mg compared with the 700 mg dose on the TOVA ADHD score.