Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol
Phase 3
Recruiting
- Conditions
- Binge-Eating Disorder
- Interventions
- Registration Number
- NCT06413433
- Lead Sponsor
- Axsome Therapeutics, Inc.
- Brief Summary
ENGAGE (Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the efficacy and safety of solriamfetol for the treatment of binge eating disorder (BED) in adults.
- Detailed Description
Eligible subjects must have a diagnosis of BED according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. Subjects will be randomized in a 1:1:1 ratio to receive solriamfetol (150 or 300 mg) or placebo, once daily for 12 weeks.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 450
Inclusion Criteria
- Primary diagnosis of BED 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 12 weeks Placebo Placebo Up to 12 weeks Solriamfetol 300 mg Solriamfetol 300 mg Up to 12 weeks
- Primary Outcome Measures
Name Time Method Change from Baseline to Week 12 in number of binge eating episodes 12 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clinical Research Site
🇺🇸Draper, Utah, United States