Solriamfetol for Binge Eating Disorder

Recruiting at 17 trial locations

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Axsome Therapeutics, Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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

Eligibility Criteria

This trial is for adults with Binge Eating Disorder (BED) who are looking to participate in a study evaluating the long-term safety and effectiveness of a medication called Solriamfetol. Specific eligibility criteria details were not provided.

Inclusion Criteria

Completion of the treatment period in Study SOL-BED-301

Able to comply with study procedures

Exclusion Criteria

Significant change in vital signs, medical history or concomitant medications since enrolling in the SOL-BED-301 study which, in the opinion of the Investigator or the Medical Monitor, would render the subject unsuitable to receive solriamfetol or participate in the study

Treatment Details

Interventions

• Solriamfetol (Other)

Trial Overview The study is testing three different doses of Solriamfetol (75mg, 150 mg, or 300 mg) to determine its safety and efficacy over an extended period for treating BED in adults. It's an open-label, Phase 3 trial conducted across multiple centers.

Participant Groups

Group I: Solriamfetol Experimental Treatment 1 Intervention

Up to 52 weeks.

Who Is Running the Clinical Trial?

Axsome Therapeutics, Inc.

Lead Sponsor

Trials

34

Recruited

11,600+