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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)

Who can join

Ages 18 to 55 · All sexes

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.

About the study

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.

What is being tested

• Solriamfetol 150 mg (drug)
• Solriamfetol 300 mg (drug)
• Placebo (drug)

Sponsor: Axsome Therapeutics, Inc. · Participants: 450 · Started: Apr 26, 2024

Contact the study team

• Study Director · Phone: 212-332-5061

Official record on ClinicalTrials.gov — NCT06413433

Locations in the U.S.

Conditions

• Binge-Eating Disorder

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.