Solriamfetol for Binge Eating Disorder

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Lindner Center of HOPE

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial tests solriamfetol, a medication that balances brain chemicals, in adults with Binge Eating Disorder (BED) to see if it can reduce their binge eating episodes.

Research Team

Eligibility Criteria

This trial is for adults aged 18-65 with Binge Eating Disorder (BED), experiencing significant distress and at least three binge-eating days per week. They must meet DSM-5 criteria for BED without a history of bulimia or anorexia nervosa. Excluded are pregnant individuals, those with recent substance abuse, serious psychiatric or medical conditions, uncontrolled hypertension or heart issues, misuse of stimulants, and anyone on certain medications.

Inclusion Criteria

You don't have episodes of excessive eating that only happen during bulimia nervosa or anorexia nervosa.

You have episodes of binge eating at least once a week for the past three months.

You often have episodes of eating a lot of food in a short time and feel like you can't control it.

Exclusion Criteria

Body mass index (BMI) ≤ 18 mg/kg2.

I am not on medication that could interfere with the study drug.

I have not started any new mental health or weight loss treatments for binge eating disorder in the last 3 months.

Treatment Details

Interventions

• Solriamfetol (Dopamine and Norepinephrine Reuptake Inhibitor)

Trial Overview The study tests the effectiveness and safety of solriamfetol—a drug affecting dopamine and norepinephrine—in treating BED against a placebo. Participants will be randomly assigned to receive either solriamfetol or a placebo to compare outcomes.

Participant Groups

Group I: Solriamfetol Active Control 1 Intervention

All medication will be 37.5 mg encapsulated soriamfetol tablets or matching encapsulated placebo tablets supplied in numbered containers for dispensing to patients. The minimum dose of solriamfetol during the trial will be 37.5 mg/day; the maximum dose will be 150 mg/day. At the Baseline Visit (Visit 0), participants will be instructed to take one capsule of solriamfetol 37.5 mg or matching placebo in the morning for the first 7 days. Thereafter, at Visit 1, solriamfetol or placebo will be increased to 75 mg/day, if tolerated. Beginning on day 15 (Visit 2), solriamfetol or placebo will be increased to 150 mg/day, if tolerated. Study medication dosage may be decreased, or a scheduled increase may not be made, because of side effects. Study medication will be administered as a single daily dose in the morning.

Group II: Placebo Placebo Group 1 Intervention

Placebo (i.e., inactive compound for comparison)

Who Is Running the Clinical Trial?

Lindner Center of HOPE

Lead Sponsor

Trials

29

Recruited

1,400+

Jazz Pharmaceuticals

Industry Sponsor

Trials

252

Recruited

35,100+

Bruce C. Cozadd

Jazz Pharmaceuticals

Chief Executive Officer since 2009

BA in Economics from Yale University, MBA from Stanford University

Dr. Austin

Jazz Pharmaceuticals

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland