A Phase 3, Randomized, Double-blind, Placebo-controlled Trial of Solriamfetol in Adults With ADHD.
Overview
- Phase
- Phase 3
- Intervention
- Solriamfetol 150 mg
- Conditions
- ADHD
- Sponsor
- Axsome Therapeutics, Inc.
- Enrollment
- 516
- Locations
- 42
- Primary Endpoint
- Change from Baseline to Week 6 in the AISRS total score
- Status
- Completed
- Last Updated
- 2 months ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Solriamfetol 150 mg
Up to 6 weeks
Intervention: Solriamfetol 150 mg
Solriamfetol 300 mg
Up to 6 weeks
Intervention: Solriamfetol 300 mg
Placebo
Up to 6 weeks
Intervention: Placebo
Outcomes
Primary Outcomes
Change from Baseline to Week 6 in the AISRS total score
Time Frame: 6 weeks
Adult ADHD Investigator Symptom Report Scale (AISRS)