Axsome Begins Phase 3 ADHD Trial in 468 Children with Solriamfetol
AXSM•Axsome Therapeutics has dosed the first patient in FOCUS-2, a Phase 3 trial evaluating solriamfetol in 468 children aged 6 to <12 with ADHD. Patients are randomized 1:1:1 to two solriamfetol doses or placebo for six weeks, with ADHD-RS-5 score change as the primary endpoint.
1. FOCUS-2 Trial Launch
Axsome Therapeutics has dosed the first patient in its FOCUS-2 Phase 3 trial, marking the start of a pediatric study of solriamfetol in children aged 6 to less than 12 with ADHD.
2. Study Design and Endpoints
The randomized, double-blind, placebo-controlled multicenter trial will enroll approximately 468 patients in a 1:1:1 ratio to receive one of two solriamfetol doses or placebo over six weeks, with the change in ADHD-RS-5 total score from baseline to week 6 as the primary efficacy measure.
3. Development Program Context
FOCUS-2 complements the ongoing FOCUS-3 trial in adolescents aged 12 to less than 18, advancing solriamfetol through Axsome’s central nervous system portfolio aimed at addressing ADHD and related neuropsychiatric disorders.
