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Psych Congress  

Comparison of Two Doses of MDX (Metadoxine Extended Release) and Placebo in Adults with Predominantly Inattentive Attention-Deficit/Hyperactivity Disorder

Authors  
Jonathan Rubin, MD, MBA
Iris Manor, MD
Yaron Daniely, PhD, MBA
Lenard Adler, MD
Sponsor  
Alcobra, Ltd

Metadoxine extended release (MDX) is in clinical development for the treatment of ADHD. A 6-week, phase 2b, randomized-controlled trial in 120 adults with ADHD demonstrated significant improvement of ADHD symptoms in patients treated with 1400 mg MDX compared with placebo. The study demonstrated a rapid onset of effect for MDX, and suggested a large effect in patients with predominantly inattentive attention-deficit/hyperactivity disorder (PI-ADHD). To investigate the onset of effect in adult patients with PI-ADHD, the efficacy of single-dose administration of MDX (1400 mg and 700 mg) was evaluated 3 to 5 hours after administration compared with placebo. A single-center, randomized, double-blind, placebo-controlled, crossover, single-dose study was conducted in 36 adult patients with PI-ADHD. Eligible patients were randomized in a 1:1:1 ratio to 1 of 3 treatment sequences varying the order of a single administration of MDX 1400 mg, MDX 700 mg, and placebo given approximately 1 week apart. The primary efficacy assessment was the Test of Variables of Attention ADHD score (TOVA ADHD). Secondary assessments included TOVA response rates and subscores. Safety assessments included adverse events, discontinuations, and vital sign measurements. The mean difference in TOVA ADHD score was statistically significant in patients with PI-ADHD following a single 1400-mg MDX dose vs placebo (mean difference [SD], 2.0 [4.2]; P = .009). No significant differences were observed between the 700-mg MDX dose and placebo. Both MDX doses exhibited favorable safety profiles. This study demonstrates the rapid response of a single dose of MDX 1400 mg in adult patients with PI-ADHD.

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