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The MEASURE Study - A Phase 3 Study of MDX 1400 mg Daily Compared With Placebo in Adults With ADHD

Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial

Official title:
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)

Clinical Trial Summary

This study is a multi-center, randomized, double-blind, placebo-controlled, phase 3 study of MDX (1400 mg daily) for 10 weeks compared with placebo in adults with ADHD.

The study will be comprised of Screening, Washout (if required), Treatment (total of 10 weeks) and Follow-up periods. Approximately 750 patients will be enrolled and undergo initial eligibility assessments.

Clinical Trial Description

- A 10-week randomized, multi-center, double-blind, placebo-controlled, phase 3 study of MDX (1400 mg daily) for 10 weeks compared with placebo in adults with ADHD.

- The study will be comprised of Screening, Washout (if required), Treatment (total of 10 weeks) and Follow-up periods. Approximately 750 patients will be enrolled and undergo initial eligibility assessments.

- Subjects requiring a washout will undergo a Washout period where ADHD medication is discontinued (21 days for atomoxetine, 14 days for other ADHD medications). These subjects will have an Interim Visit (off drug) on or about Day -10 (Day -10 to Day -3) for CAARS-Inv assessment at the end of the Washout period.

- Subjects will be randomly assigned to placebo/MDX for a total treatment duration of up to ten weeks.

There will be a one week Follow-up period after the last dose of study treatment or early termination. ;

Study Design

Related Conditions & MeSH terms

  • Attention Deficit Disorder with Hyperactivity
  • Attention Deficit Hyperactivity Disorder (ADHD)
  • Hyperkinesis
Clinical Trial Details
NCT number NCT02477748
Study type Interventional
Source Alcobra Ltd.
Contact
Status Terminated
Phase Phase 3
Start date June 2015
Completion date January 2017
View Details
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