What is solriamfetol studying for binge eating disorder?

Solriamfetol is being studied to see how it affects binge eating disorder in adults. Researchers want to learn if it can reduce the number of binge eating episodes and assess its safety. The study is sponsored by Axsome Therapeutics, Inc. and aims to provide new information for managing BED.

Who may be eligible for this binge eating disorder clinical trial?

Adults aged 18 to 55 years with a diagnosis of binge eating disorder may be eligible. Both males and females can participate. People who have taken solriamfetol before or cannot follow the study procedures may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this binge eating disorder clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel needs.

Actively Recruiting

Phase 3

Age: 18Years - 55Years

All Genders

ID06413433

A Phase 3, Randomized, Double-blind, Placebo-Controlled Trial of Solriamfetol in Adults With Binge Eating Disorder

Led by Axsome Therapeutics, Inc. · Updated on 2025-11-21

450

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating solriamfetol, a drug that affects TAAR-1, dopamine, and norepinephrine, for treating binge eating disorder BED in adults. This Phase 3 trial is randomized, double-blind, and placebo-controlled, designed to assess both the effectiveness and safety of solriamfetol in people diagnosed with BED according to DSM-5 criteria. Participants will be randomly assigned to one of three groups solriamfetol 150 mg, solriamfetol 300 mg, or placebo. Each participant will take their assigned tablets once daily for up to 12 weeks. The study compares these doses with placebo to understand the drugs impact on BED symptoms. During the 12-week treatment period, researchers will monitor changes in the number of binge eating episodes from the start of the study to week 12. Participants will also undergo assessments to check safety and adherence. The total duration of participation will be up to 12 weeks, during which the effects of the treatment will be carefully evaluated.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 55Years

All Genders

Eligibility Criteria

You may qualify if you...

Primary diagnosis of binge eating disorder according to DSM-5 criteria
Provides written informed consent before any study procedures
Male or female aged 18 to 55 years inclusive

You will not qualify if you...

Prior exposure to solriamfetol (Sunosi) through clinical study or prescription
Unable to comply with study procedures
Medically inappropriate for study participation as judged by the investigator

Research Team

Study Director

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here