CompletedPhase 3

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

United States516 participantsStarted 2023-07-06

Plain-language summary

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 efficacy and safety of solriamfetol in adults with ADHD.

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change from Baseline to Week 6 in the AISRS total score

Timeframe: 6 weeks

Trial details

NCT IDNCT05972044

SponsorAxsome Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-02-07

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