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)

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)

Discontinued
Phase of Trial: Phase III

Latest Information Update: 24 Jan 2017

At a glance

  • Drugs Metadoxine (Primary)
  • Indications Attention-deficit hyperactivity disorder
  • Focus Registrational; Therapeutic Use
  • Acronyms MEASURE
  • Sponsors Alcobra
  • Most Recent Events

    • 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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