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COMPLETEDPhase 3NCT05972044

A Study to Assess the Efficacy and Safety of Solriamfetol in Subjects With ADHD (FOCUS)

FOCUS (Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol) is a Phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel- group trial to assess the effica...

Lead sponsor: Axsome Therapeutics, Inc.•42 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Axsome Therapeutics, Inc.

Eligible subjects must have a primary diagnosis of ADHD based on the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) criteria. Subjects will be randomized in a 1:1:1 ratio to be treated with solriamfetol 150 mg, solriamfetol 300 mg, or placebo, once daily for 6 weeks.

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Primary diagnosis of ADHD according to DSM-5 criteria.
•Provides written informed consent to participate in the study before the conduct of any study procedures.
•Male or female, aged 18 to 55 inclusive.

Exclusion Criteria

•Prior exposure to solriamfetol/Sunosi, through either a clinical study or prescription.
•Unable to comply with study procedures.
•Medically inappropriate for study participation in the opinion of the investigator.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: February 10, 2026Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE3

Enrollment516

Start dateJul 2023

Last updatedFeb 10, 2026

Condition

Locations shown

Clinical Research Site

Encino, California

Clinical Research Site

Garden Grove, California

Clinical Research Site

Newport Beach, California

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 10, 2026Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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