A Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Subjects With Binge Eating Disorder

NCT06878976 · tracked via the Priya Life Science USA tracker

Sponsor

Axsome Therapeutics, Inc.

Phase

Phase 3

Started

2025-02-20

Last updated

2026-08-11

Condition(s) studied

Binge-Eating Disorder

Investigational drug(s) / intervention(s)

SolriamfetolPlacebo

Solriamfetol: Solriamfetol tablets, taken once daily

Placebo: Placebo tablets, taken once daily

Study summary

This is a Phase 3, multi-center, open-label and randomized withdrawal study to evaluate the long-term safety and efficacy of solriamfetol in the treatment of binge eating disorder (BED) in adults.

Eligibility

Sex

ALL

Min age

18 Years

Max age

56 Years

Healthy volunteers

Inclusion Criteria: * Completion of the treatment period in Study SOL-BED-301. Exclusion Criteria: * Unable to comply with study procedures. * Medically inappropriate for study participation in the opinion of the investigator.

Primary outcome measure(s)

Time from randomization to relapse of binge eating in the RW segment — Up to 24 weeks

Trial sites (33)

Facility	City	Region
Clinical Research Site	Encino	California
Clinical Research Site	Long Beach	California
Clinical Research Site	Santa Ana	California
Clinical Research Site	Walnut Creek	California
Clinical Research Site	West Covina	California
Clinical Research Site	Cromwell	Connecticut
Clinical Research Site	Fort Myers	Florida
Clinical Research Site	Jacksonville	Florida
Clinical Research Site	Lauderhill	Florida
Clinical Research Site	Miami	Florida
Clinical Research Site	Miami	Florida
Clinical Research Site	Miami Lakes	Florida
Clinical Research Site	Orlando	Florida
Clinical Research Site	Marietta	Georgia
Clinical Research Site	Overland Park	Kansas
Clinical Research Site	Boston	Massachusetts
Clinical Research Site	Saint Charles	Missouri
Clinical Research Site	Cherry Hill	New Jersey
Clinical Research Site	Mount Kisco	New York
Clinical Research Site	New York	New York
Clinical Research Site	Raleigh	North Carolina
Clinical Research Site	Cincinnati	Ohio
Clinical Research Site	Mason	Ohio
Clinical Research Site	Middleburg Heights	Ohio
Clinical Research Site	North Canton	Ohio
Clinical Research Site	Portland	Oregon
Clinical Research Site	Allentown	Pennsylvania
Clinical Research Site	North Charleston	South Carolina
Clinical Research Site	Memphis	Tennessee
Clinical Research Site	Austin	Texas
Clinical Research Site	Austin	Texas
Clinical Research Site	Dallas	Texas
Clinical Research Site	San Antonio	Texas

More Axsome Therapeutics, Inc. trials in the USA

SUNOSI® (Solriamfetol) Pregnancy Registry Recruiting

Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN) Recruiting

Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol Recruiting

Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-3) Recruiting

An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD Enrolling by invitation

Other trials for the same condition

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

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06878976 on ClinicalTrials.gov ↗ ← All trials in the USA