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Clinical Trials in the USA / NCT06878976
Enrolling by invitation Phase 3

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)

Solriamfetol →Placebo

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
No
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)

FacilityCityRegionStatus
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

Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol Recruiting
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2) Recruiting
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT) 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

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