NCT02477748

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

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: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 283 (actual)
• Sponsor: Alcobra Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Attention Deficit Hyperactivity Disorder (ADHD)

Interventions

Type	Name	Description
DRUG	MDX	Immediate-release/slow-release,bilayer tablet PO of 1400 mg, taken once daily for 10 weeks.
DRUG	Placebo	Tablet PO, taken once daily for 10 weeks.

Timeline

• Start date: 2015-06-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2015-06-23
• Last updated: 2017-01-19

Locations

38 sites across 2 countries: United States, Israel