Study detail
RecruitingPhase 3
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