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NCT06413433 Clinical Trial

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

Binge-Eating Disorder Clinical Trial

— ENGAGE  

Official title:
A Phase 3, Randomized, Double-blind, Placebo-Controlled Trial of Solriamfetol in Adults With Binge Eating Disorder (BED)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06413433
Other study ID # SOL-BED-301
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date April 26, 2024
Est. completion date December 2025

Study information
Verified date May 2024
Source Axsome Therapeutics, Inc.
Contact Study Director
Phone 212-332-5061
Email sol-bed-301@axsome.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 450
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Solriamfetol 150 mg
Solriamfetol tablets, taken once daily
• Solriamfetol 300 mg
Solriamfetol tablets, taken once daily
• Placebo
Placebo tablets, taken once daily

Locations
Country Name City State
United States Clinical Research Site Austin Texas
United States Clinical Research Site Cherry Hill New Jersey
United States Clinical Research Site Clermont Florida
United States Clinical Research Site Encino California
United States Clinical Research Site Jacksonville Florida
United States Clinical Research Site Marietta Georgia
United States Clinical Research Site Memphis Tennessee
United States Clinical Research Site Methuen Massachusetts
United States Clinical Research Site Newport Beach California
United States Clinical Research Site Orlando Florida
United States Clinical Research Site Orlando Florida
United States Clinical Research Site Overland Park Kansas
United States Clinical Research Site Raleigh North Carolina
United States Clinical Research Site Saint Charles Missouri
United States Clinical Research Site San Antonio Texas
United States Clinical Research Site San Diego California

Sponsors (1)
Lead Sponsor Collaborator
Axsome Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from Baseline to Week 12 in number of binge eating episodes 12 weeks
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