Solriamfetol for Binge Eating Disorder
(ENGAGE Trial)
Trial Summary
What is the purpose of this trial?
This trial examines the effectiveness and safety of solriamfetol for treating binge eating disorder (BED) in adults. Researchers will compare solriamfetol, administered in two different doses, to a placebo (a pill with no active drug) over 12 weeks. The trial aims to determine if solriamfetol can reduce the urge to binge eat by affecting certain brain chemicals. Adults diagnosed with BED who have not previously tried solriamfetol may be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the potential availability of a new treatment.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
Is there any evidence suggesting that solriamfetol is likely to be safe for humans?
Solriamfetol is approved by the FDA for the treatment of two sleep conditions (excessive sleepiness in narcolepsy and obstructive sleep apnea). In studies with people with these conditions, solriamfetol was generally well tolerated, and 3% of participants stopped solriamfetol because of side effects. However, side effects can vary among individuals and among people with different conditions.
Why do researchers think this study treatment might be promising for binge eating disorder?
Researchers are studying solriamfetol for binge eating disorder because it may affect brain chemicals involved in the control of urges. It offers a different approach compared to some existing treatments, such as cognitive behavioral therapy and medications like lisdexamfetamine (Vyvanse®). Since solriamfetol is already approved for other conditions, researchers have prior safety information, which supports studying it further in people with binge eating disorder.
Eligibility Criteria
This trial is for adults with binge eating disorder (BED). Participants must not have other conditions that could interfere with the study, such as bulimia or other significant psychiatric disorders. They should be able to follow the trial procedures and take medication as directed.Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to pariticpate in the trial.
Treatment
Participants receive 2 solriamfetol (150 or 300 mg) or placebo once daily for 12 weeks.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Who Is Running the Clinical Trial?
Axsome Therapeutics, Inc.
Lead Sponsor
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