A Phase 2, Randomized, Parallel-Group, Double-Blind, Study to Evaluate the Safety and Efficacy of ALKS 7290 Compared to Placebo in Adult Participants With Attention Deficit Hyperactivity Disorder

Alkermes, Inc.

Summary

The purpose of this study is to measure safety and the improvement in symptoms in subjects with ADHD when taking ALKS 7290 tablets compared with placebo tablets.

Eligibility

Age range: 18–65 years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Meets the Diagnostic and Statistical Manual of Mental Disorders -5 criteria for ADHD, as confirmed by the Mini-International Neuropsychiatric Interview (MINI) for ADHD Studies 7.0.2. * Is otherwise healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring. Participants must be stable on permitted medication for 2 months prior to first visit, without anticipated changes to dose. * AISRS total score of ≥26 * CGI-S score ≥ 4 (moderately ill or worse) * Has a Body Mass Index within 18 to 35 kg/m2 E…

Interventions

Drug
ALKS 7290
ALKS 7290 tablets taken daily, orally, for 4 weeks
Drug
Placebo
Placebo capsule taken daily

Locations (2)

Alkermes Investigator Site
Chino, California
Alkermes Investigator Site
Maitland, Florida

A Phase 2, Randomized, Parallel-Group, Double-Blind, Study to Evaluate the Safety and Efficacy of ALKS 7290 Compared to Placebo in Adult Participants With Attention Deficit Hyperactivity Disorder

Summary

Eligibility

Interventions

Locations (2)

Compensation

Run this study?

Details

Conditions