RECRUITINGPhase 3INTERVENTIONAL
Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol
A Phase 3, Randomized, Double-blind, Placebo-Controlled Trial of Solriamfetol in Adults With Binge Eating Disorder (BED)
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- Primary diagnosis of BED according to DSM-5 criteria.
- Provides written willing to sign a consent form to participate in the study before the conduct of any study procedures.
- Male or female, aged 18 to 55 inclusive.
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
Solriamfetol 150 mg
Solriamfetol tablets, taken once daily
DRUG
Solriamfetol 300 mg
Solriamfetol tablets, taken once daily
DRUG
Placebo
Placebo tablets, taken once daily
Locations (20)
Clinical Research Site
Encino, California, United States
Clinical Research Site
Garden Grove, California, United States
Clinical Research Site
Long Beach, California, United States
Clinical Research Site
Newport Beach, California, United States
Clinical Research Site
San Diego, California, United States
Clinical Research Site
Santa Ana, California, United States
Clinical Research Site
Walnut Creek, California, United States
Clinical Research Site
West Covina, California, United States
Clinical Research Site
Colorado Springs, Colorado, United States
Clinical Research Site
Cromwell, Connecticut, United States
Clinical Research Site
Clermont, Florida, United States
Clinical Research Site
Fort Myers, Florida, United States
Clinical Research Site
Hialeah, Florida, United States
Clinical Research Site
Jacksonville, Florida, United States
Clinical Research Site
Lauderhill, Florida, United States
Clinical Research Site
Miami, Florida, United States
Clinical Research Site
Miami, Florida, United States
Clinical Research Site
Miami Lakes, Florida, United States
Clinical Research Site
Orlando, Florida, United States
Clinical Research Site
Orlando, Florida, United States