A Phase 3 interventional study of Solriamfetol 150 mg and Solriamfetol 300 mg in Binge-Eating Disorder, sponsored by Axsome Therapeutics, Inc.. Recruiting at 45 sites in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by Axsome Therapeutics, Inc. · Phase 3, Interventional, and Treatment
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.
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.
259 studies on the registry are indexed under Binge-Eating Disorder; 54 are open to participants now.
This study's planned enrollment of 450 is above the median of 76 across 217 interventional studies indexed under Binge-Eating Disorder.
Browse Binge-Eating Disorder studies →Axsome Therapeutics, Inc. is the lead sponsor of 36 studies on the registry; 12 are open to participants now.
Of its 20 completed or terminated interventional studies of FDA-regulated products, 11 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Up to 12 weeks
Drug: Solriamfetol 150 mg
Up to 12 weeks
Drug: Solriamfetol 300 mg
Up to 12 weeks
Drug: Placebo
Solriamfetol tablets, taken once daily
Solriamfetol tablets, taken once daily
Placebo tablets, taken once daily
Change from Baseline to Week 12 in number of binge eating episodes
Time frame: 12 weeks
Plan to share: No
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Axsome Therapeutics, Inc.