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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-55
SponsorAxsome Therapeutics, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Solriamfetol 150 mg
  • Solriamfetol 300 mg
  • Placebo

Treatment groups

450 Participants
are divided into 3 treatment groups

Locations

45
California
Clinical Research Site91316, Encino United States
Clinical Research Site92845, Garden Grove United States
Clinical Research Site90806, Long Beach United States
Clinical Research Site92660, Newport Beach United States

Sponsors and collaborators

Axsome Therapeutics, Inc.

Lead sponsor