Open-Label Safety Study of Solriamfetol in Subjects with Binge Eating Disorder
Launched by AXSOME THERAPEUTICS, INC. · Mar 14, 2025
Trial Information
Current as of April 29, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
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.
Gender
ALL
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.
About Axsome Therapeutics, Inc.
Axsome Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapies for central nervous system (CNS) disorders. With a commitment to addressing unmet medical needs, Axsome leverages its proprietary drug development platform to advance a diverse pipeline of product candidates targeting conditions such as depression, migraine, and insomnia. The company is dedicated to improving patient outcomes through rigorous clinical research and collaboration with healthcare professionals, aiming to transform the treatment landscape for patients suffering from debilitating neurological and psychiatric conditions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Jacksonville, Florida, United States
Encino, California, United States
Hialeah, Florida, United States
Memphis, Tennessee, United States
Austin, Texas, United States
Cromwell, Connecticut, United States
Cincinnati, Ohio, United States
Miami, Florida, United States
Marietta, Georgia, United States
Overland Park, Kansas, United States
Saint Charles, Missouri, United States
Mount Kisco, New York, United States
New York, New York, United States
Raleigh, North Carolina, United States
Walnut Creek, California, United States
Fort Myers, Florida, United States
North Canton, Ohio, United States
Dallas, Texas, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported