The MEASURE Study - A Phase 3 Study of MDX 1400 mg Daily Compared With Placebo in Adults With ADHD
NCT02477748 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 283
Last updated 2017-01-19
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.
Conditions
- Attention Deficit Hyperactivity Disorder (ADHD)
Interventions
- DRUG
-
MDX
Immediate-release/slow-release,bilayer tablet PO of 1400 mg, taken once daily for 10 weeks.
- DRUG
-
Tablet PO, taken once daily for 10 weeks.
Sponsors & Collaborators
-
Alcobra Ltd.
lead INDUSTRY
Principal Investigators
-
Jeffrey Newcorn, MD · Icahn School of Medicine at Mount Sinai
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-06-30
- Primary Completion
- 2017-01-31
- Completion
- 2017-01-31
Countries
- United States
- Israel
Study Locations
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