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Phase 2
Age: 18Years - 65Years
All Genders
ID07755410

Evaluating ALKS 7290 Tablets for Safety and Symptom Improvement Compared to Placebo in Adults with ADHD

Led by Alkermes, Inc. · Updated on 2026-08-10

312

Participants Needed

2

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and symptom improvement of ALKS 7290 tablets compared with placebo in adults with Attention Deficit Hyperactivity Disorder ADHD. The study focuses on adults aged 18 to 65 who meet specific diagnostic criteria for ADHD and aims to assess how the medication impacts their symptoms over time. Participants are randomly assigned to receive one of three dose levels of ALKS 7290 tablets or a daily placebo capsule. The treatment is taken orally once daily for 4 weeks. This phase 2 trial uses a parallel design with triple masking to compare the effects of ALKS 7290 against placebo. During the study, participants undergo medical evaluations including physical exams, lab tests, and cardiac monitoring to ensure safety. Symptom changes are measured using the Attention Deficit Disorder Investigator Symptom Rating Scale AISRS and Clinical Global Impression-Severity CGI-S scale from baseline to week 4. Adverse events are monitored up to 6 weeks. The total study period extends from August 2026 until July 2027.

CONDITIONS

Brief Title

A Study to Evaluate Safety and Efficacy of ALKS 7290 Compared With Placebo in Adult Participants With Attention Deficit Hyperactivity Disorder (ALKS 7290-201)

Research Team

G

Global Clinical Services

G

Global Clinical Services

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