Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Solriamfetol 150 mg, Solriamfetol 300 mg, Placebo.
- Who it may be relevant to
- Registry conditions: Binge-Eating Disorder. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 3, Randomized, Double-blind, Placebo-Controlled Trial of Solriamfetol in Adults With Binge Eating Disorder (BED)
Overview
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.
Detailed description
Eligible subjects must have a diagnosis of BED according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. Subjects will be randomized in a 1:1:1 ratio to receive solriamfetol (150 or 300 mg) or placebo, once daily for 12 weeks.
Interventions
- 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
Primary outcome measures
- Change from Baseline to Week 12 in number of binge eating episodes [Time frame: 12 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 45 centers
- Clinical Research Site — Encino
- Clinical Research Site — Garden Grove
- Clinical Research Site — Long Beach
- Clinical Research Site — Mission Viejo
- Clinical Research Site — San Diego
- Clinical Research Site — Santa Ana
- Clinical Research Site — Walnut Creek
- Clinical Research Site — West Covina
- … and 37 more centers
Identifiers
NCT: NCT06413433 · SOL-BED-301