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RecruitingPhase 3

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

Axsome Therapeutics, Inc. · NCT06413433

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–55 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
450
US sites recruiting
38
Study start
April 26, 2024
Record last updated
July 28, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Solriamfetol 150 mg; Solriamfetol 300 mg; Placebo

Conditions: Binge-Eating Disorder

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

Study contacts (from the official record)

  • Study Director · 212-332-5061 · sol-bed-301@axsome.com
Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating… (NCT06413433) | Bored Studies