Actively Recruiting
Phase 3 Trial Evaluating Solriamfetol Capsules in Children Aged 6 to 11 With ADHD Over 6 Weeks
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 conducting a Phase 3 clinical trial to evaluate the safety and effectiveness of solriamfetol in children aged 6 to under 12 years diagnosed with ADHD based on the DSM-5 criteria. This study is randomized, double-blind, and placebo-controlled, aiming to provide reliable data on solriamfetols 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 capsule once daily for six weeks. This parallel-group design allows comparison between different doses of solriamfetol and placebo over the treatment period. During the study, children will be monitored regularly for changes in ADHD symptoms using the ADHD-RS-5 total score from baseline to week 6. Safety assessments and adherence to the daily capsule regimen will be observed. The trial will last six weeks, with data collected to assess how solriamfetol affects ADHD symptoms and to monitor any side effects.
CONDITIONS
Brief Title
A Study to Assess the Efficacy and Safety of Solriamfetol in Children With ADHD
Research Team
S
Study Director
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