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

Sponsors and collaborators