Open-Label Safety Study of Solriamfetol in Subjects With Binge Eating Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Solriamfetol 75mg, 150 mg, or 300 mg.
- Who it may be relevant to
- Registry conditions: Binge-Eating Disorder. Basic parameters: 18 years — 56 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open-Label Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Adults With Binge Eating Disorder
Overview
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.
Detailed description
Eligible subjects will have previously completed the SOL-BED-301 (ENGAGE) study.
This study consists of a Baseline Visit, a 2-week Titration Phase, and a 50-week Maintenance Phase, followed by a 1-week follow-up period.
Interventions
- Drug Solriamfetol 75mg, 150 mg, or 300 mg
Taken once daily.
Primary outcome measures
- Long-term Safety [Time frame: Up to 52 weeks.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 31 centers
- Clinical Research Site — Encino
- Clinical Research Site — Long Beach
- Clinical Research Site — Santa Ana
- Clinical Research Site — Walnut Creek
- Clinical Research Site — West Covina
- Clinical Research Site — Cromwell
- Clinical Research Site — Fort Myers
- Clinical Research Site — Hialeah
- … and 23 more centers
Identifiers
NCT: NCT06878976 · SOL-BED-303