A Phase 3, Randomized, Double-blind, Placebo-Controlled Trial of Solriamfetol in Adults With Binge Eating Disorder (BED)
Axsome Therapeutics, Inc.
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.
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.
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- No
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.
Interventions
- DrugSolriamfetol 150 mg
Solriamfetol tablets, taken once daily
- DrugSolriamfetol 300 mg
Solriamfetol tablets, taken once daily
- DrugPlacebo
Placebo tablets, taken once daily
Locations (45)
- Clinical Research SiteEncino, California
- Clinical Research SiteGarden Grove, California
- Clinical Research SiteLong Beach, California
- Clinical Research SiteNewport Beach, California
- Clinical Research SiteSan Diego, California
- Clinical Research SiteSanta Ana, California