NCT07717879PHASE3Recruiting

A Study to Assess the Efficacy and Safety of Solriamfetol in Children With ADHD

Axsome Therapeutics, Inc.

Start Date

7/6/2026

Completion Date

6/30/2028

Summary

This study is a Phase 3, multi-center, randomized, 6-week, double-blind, placebo-controlled, parallel-group trial to assess the efficacy and safety of solriamfetol in children aged 6 to \<12 years with ADHD.

Detailed Description

Eligible subjects are children, 6 to \<12 years of age, with a primary diagnosis of ADHD based on criteria established by the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) criteria. Subjects will be randomized in a 1:1:1 ratio to receive solriamfetol dose A, solriamfetol dose B or placebo once daily for 6 weeks.

Eligibility Criteria

Age Range: 6 years to 11 years

Inclusion Criteria: * Male or female, aged 6 to \<12 years. * Primary diagnosis of ADHD according to DSM-5 criteria. * Has parents/legal guardians provide written informed consent and has child provide written informed assent to participate in the study before the conduct of any study procedures. Exclusion Criteria: * Unable to comply with study procedures. * Medically inappropriate for study participation in the opinion of the investigator.

Interventions

DRUG

Solriamfetol Dose A

United States