Home › Attention Deficit Hyperactivity Disorder › NCT07717892

Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-3)

A Phase 3, Randomized, 6-Week, Double-blind, Placebo- Controlled Trial of Solriamfetol in Adolescents Aged 12 to <18 Years With Attention Deficit Hyperactivity Disorder (ADHD)

Who can join

Ages 12 to 17 · All sexes

Inclusion Criteria:

* Male or female, aged 12 to \<18 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.

About the study

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 adolescents aged 12 to \<18 years with ADHD.

What is being tested

• Solriamfetol Dose A (drug)
• Solriamfetol Dose B (drug)
• Placebo (drug)

Sponsor: Axsome Therapeutics, Inc. · Participants: 468 · Started: Jun 25, 2026

Contact the study team

• Study Director · Phone: 212-332-5061

Official record on ClinicalTrials.gov — NCT07717892

Locations in the U.S.

Conditions

• Attention Deficit Hyperactivity Disorder

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.