Trial Profile

A 10-week Randomized, Multicenter, Double-blind, Parallel, Fixed-dose Study of MDX (Metadoxine Immediate-release/Slow-release, Bilayer Tablet) 1400 mg Compared With Placebo in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

Status: Discontinued

Phase of Trial: Phase III

Latest Information Update: 24 Jan 2017

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At a glance

18 Jan 2017 Status changed from suspended to discontinued.
17 Jan 2017 Primary endpoint (18-item total ADHD symptom score of the Conners Adult ADHD Rating Scale:O-SV (with the investigator as observer) with adult ADHD prompts (CAARS investigator)), has not been met, as per an Alcobra media release.
09 Jan 2017 According to an Alcobra Ltd. media release, the US FDA has agreed to review the data collected thus far in this trial and consider it in a future NDA submission of metadoxine extnded release for treatment of ADHD.

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