Actively Recruiting
Phase 3 Randomized Study Evaluating Solriamfetol Capsules Daily for Adolescents Aged 12 to 17 Years With ADHD
Led by Axsome Therapeutics, Inc. · Updated on 2026-07-21
468
Participants Needed
9
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of solriamfetol in adolescents aged 12 to under 18 years who have been diagnosed with attention deficit hyperactivity disorder ADHD based on DSM-5 criteria. This Phase 3, multi-center, randomized, double-blind, placebo-controlled study aims to compare two doses of solriamfetol against a placebo over a 6-week period to better understand its impact on ADHD symptoms. Participants will be randomly assigned to one of three groups solriamfetol dose A, solriamfetol dose B, or placebo. Each participant will take their assigned capsules once daily for up to 6 weeks. The study uses a parallel-group design, meaning each participant receives only one treatment throughout the trial. During the study, participants will have assessments to track changes in ADHD symptoms, specifically measured by the ADHD Rating Scale-5 ADHD-RS-5 total score from baseline to week 6. Researchers will monitor participants closely to evaluate the safety of the treatments. The total duration of participation is approximately 6 weeks, during which participants will attend scheduled visits as part of the study protocol.
CONDITIONS
Brief Title
A Study to Assess the Efficacy and Safety of Solriamfetol in Adolescents With ADHD
Research Team
S
Study Director
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