NCT06413433

Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol

A Phase 3, Randomized, Double-blind, Placebo-Controlled Trial of Solriamfetol in Adults With Binge Eating Disorder (BED)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Axsome Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Binge-Eating Disorder

Interventions

Type	Name	Description
DRUG	Solriamfetol 150 mg	Solriamfetol tablets, taken once daily
DRUG	Solriamfetol 300 mg	Solriamfetol tablets, taken once daily
DRUG	Placebo	Placebo tablets, taken once daily

Timeline

• Start date: 2024-04-26
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-05-14
• Last updated: 2025-11-21

Locations

45 sites across 1 country: United States

Regulatory

• FDA-regulated drug study