A Study to Assess the Efficacy and Safety of Solriamfetol in Subjects With ADHD (FOCUS)
Phase 3
Completed
- Conditions
- ADHD
- Interventions
- Registration Number
- NCT05972044
- Lead Sponsor
- Axsome Therapeutics, Inc.
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 516
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Solriamfetol 150 mg Solriamfetol 150 mg Up to 6 weeks Solriamfetol 300 mg Solriamfetol 300 mg Up to 6 weeks Placebo Placebo Up to 6 weeks
- Primary Outcome Measures
Name Time Method Change from Baseline to Week 6 in the AISRS total score 6 weeks Adult ADHD Investigator Symptom Report Scale (AISRS)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clinical Research Site
🇺🇸Everett, Washington, United States