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

NCT06413433

RecruitingPhase 3

Sponsor: Axsome Therapeutics, Inc.

Conditions: Binge-Eating Disorder

Interventions: Solriamfetol 150 mg, Solriamfetol 300 mg, Placebo

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to 55 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.
Locations (45)
  • Encino, California, United States
  • Garden Grove, California, United States
  • Long Beach, California, United States
  • Mission Viejo, California, United States
  • San Diego, California, United States
  • Santa Ana, California, United States
  • Walnut Creek, California, United States
  • West Covina, California, United States
  • Colorado Springs, Colorado, United States
  • Cromwell, Connecticut, United States
  • Clermont, Florida, United States
  • Fort Myers, Florida, United States
  • Jacksonville, Florida, United States
  • Lauderhill, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami Lakes, Florida, United States
  • Miami Lakes, Florida, United States
  • Orlando, Florida, United States
  • Orlando, Florida, United States
  • Marietta, Georgia, United States
  • Overland Park, Kansas, United States
  • Boston, Massachusetts, United States
  • Methuen, Massachusetts, United States
  • Saint Charles, Missouri, United States
  • Cherry Hill, New Jersey, United States
  • Princeton, New Jersey, United States
  • Mount Kisco, New York, United States
  • New York, New York, United States
  • Raleigh, North Carolina, United States
  • + 15 more on CT.gov