Clinical TrialJun 26, 2026, 07:01 AM
Axsome Doses First Patient in Phase 3 Trial for Solriamfetol in Adolescent ADHD
AI Summary
Axsome Therapeutics announced that the first patient has been dosed in the FOCUS-3 Phase 3 trial. This trial is evaluating solriamfetol as a treatment for adolescents aged 12 to less than 18 years with attention deficit hyperactivity disorder (ADHD). The randomized, double-blind, placebo-controlled study will enroll approximately 468 patients, assessing efficacy and safety over 6 weeks with the primary endpoint being the change in ADHD-RS-5 total score.
Key Highlights
- First patient dosed in FOCUS-3 Phase 3 trial for solriamfetol in adolescent ADHD.
- Trial evaluates solriamfetol in adolescents aged 12 to less than 18 years with ADHD.
- Approximately 468 patients will be randomized in a 1:1:1 ratio.
- Patients will receive one of two doses of solriamfetol or placebo for 6 weeks.
- Primary endpoint is change from baseline to week 6 in ADHD Rating Scale (ADHD-RS-5) total score.
- Solriamfetol is a dopamine and norepinephrine reuptake inhibitor (DNRI), TAAR1 agonist, and 5-HT1A agonist.
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