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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Binge-Eating Disorder

In brief

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.

Key facts

Study ID

NCT06413433

Run by

Axsome Therapeutics, Inc.

People needed

450

Starts

2024-04-26

Expected to finish

2026-12-01

Last updated by the study team

2026-07-28

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Clinical Research Site — Portland, Oregon, United States (enrolling)
• Clinical Research Site — Garden Grove, California, United States (enrolling)
• Clinical Research Site — Long Beach, California, United States (enrolling)
• Clinical Research Site — Mission Viejo, California, United States (enrolling)
• Clinical Research Site — Greenville, South Carolina, United States (enrolling)
• Clinical Research Site — North Charleston, South Carolina, United States (enrolling)
• Clinical Research Site — Memphis, Tennessee, United States (enrolling)
• Clinical Research Site — Austin, Texas, United States (enrolling)
• Clinical Research Site — Austin, Texas, United States (enrolling)
• Clinical Research Site — Dallas, Texas, United States (enrolling)
• Clinical Research Site — San Antonio, Texas, United States (enrolling)
• Clinical Research Site — Santa Ana, California, United States (enrolling)
• Clinical Research Site — Walnut Creek, California, United States (enrolling)
• Clinical Research Site — West Covina, California, United States (enrolling)
• Clinical Research Site — Colorado Springs, Colorado, United States (enrolling)
• Clinical Research Site — Cromwell, Connecticut, United States (enrolling)
• Clinical Research Site — Fort Myers, Florida, United States (enrolling)
• Clinical Research Site — Jacksonville, Florida, United States (enrolling)
• Clinical Research Site — Lauderhill, Florida, United States (enrolling)
• Clinical Research Site — Miami, Florida, United States (enrolling)
• Clinical Research Site — Miami, Florida, United States (enrolling)
• Clinical Research Site — Miami Lakes, Florida, United States (enrolling)
• Clinical Research Site — Orlando, Florida, United States (enrolling)
• Clinical Research Site — Marietta, Georgia, United States (enrolling)
• Clinical Research Site — Overland Park, Kansas, United States (enrolling)

Full record on ClinicalTrials.gov

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