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Enrolling by invitationPhase 3

A Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Subjects With Binge Eating Disorder

Key facts

Who runs it
Axsome Therapeutics, Inc.
Where
Allentown, Austin, Boston, Cherry Hill, Cincinnati, Colorado Springs, Cromwell, Dallas, Encino, Fort Myers, Jacksonville, Lauderhill, Long Beach, Marietta, Mason, Memphis, Miami, Miami Lakes, Middleburg Heights, Mount Kisco, New York, North Canton, North Charleston, Orlando, Overland Park, Portland, Raleigh, Saint Charles, San Antonio, Santa Ana, Walnut Creek, and West Covina, United StatesSee the 32 sites
Trial code
Status
Enrolling by invitation
Phase
Phase 3
People taking part
236 people, planned
Started
20 Feb 2025
Expected to end
Dec 2027
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Solriamfetol
  • Placebo
Record updated
6 November 2026

Who can take part

Age
18 years to 56 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 3 criteriaShow less

Who can take part

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

Who cannot take part

  • Unable to comply with study procedures
  • Medically inappropriate for study participation in the opinion of the investigator

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 56 years old?

Where in United States

  • Allentown, PennsylvaniaHospital not named in the registryEnrolling by invitation
  • Austin, TexasHospital not named in the registryEnrolling by invitation
  • Boston, MassachusettsHospital not named in the registryEnrolling by invitation
  • Cherry Hill, New JerseyHospital not named in the registryEnrolling by invitation
  • Cincinnati, OhioHospital not named in the registryEnrolling by invitation
  • Colorado Springs, ColoradoHospital not named in the registryEnrolling by invitation
  • Cromwell, ConnecticutHospital not named in the registryEnrolling by invitation
  • Dallas, TexasHospital not named in the registryEnrolling by invitation
  • Encino, CaliforniaHospital not named in the registryEnrolling by invitation
  • Fort Myers, FloridaHospital not named in the registryEnrolling by invitation
  • Jacksonville, FloridaHospital not named in the registryEnrolling by invitation
  • Lauderhill, FloridaHospital not named in the registryEnrolling by invitation
  • Long Beach, CaliforniaHospital not named in the registryEnrolling by invitation
  • Marietta, GeorgiaHospital not named in the registryEnrolling by invitation
  • Mason, OhioHospital not named in the registryEnrolling by invitation
  • Memphis, TennesseeHospital not named in the registryEnrolling by invitation
  • Miami, FloridaHospital not named in the registryEnrolling by invitation
  • Miami Lakes, FloridaHospital not named in the registryEnrolling by invitation
  • Middleburg Heights, OhioHospital not named in the registryEnrolling by invitation
  • Mount Kisco, New YorkHospital not named in the registryEnrolling by invitation
  • New YorkHospital not named in the registryEnrolling by invitation
  • North Canton, OhioHospital not named in the registryEnrolling by invitation
  • North Charleston, South CarolinaHospital not named in the registryEnrolling by invitation
  • Orlando, FloridaHospital not named in the registryEnrolling by invitation
  • Overland Park, KansasHospital not named in the registryEnrolling by invitation
  • Portland, OregonHospital not named in the registryEnrolling by invitation
  • Raleigh, North CarolinaHospital not named in the registryEnrolling by invitation
  • Saint Charles, MissouriHospital not named in the registryEnrolling by invitation
  • San Antonio, TexasHospital not named in the registryEnrolling by invitation
  • Santa Ana, CaliforniaHospital not named in the registryEnrolling by invitation
  • Walnut Creek, CaliforniaHospital not named in the registryEnrolling by invitation
  • West Covina, CaliforniaHospital not named in the registryEnrolling by invitation

About the trial

What the trial wants to find out

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

The 2 groups in the trial

  • SolriamfetolTreatment being tested

    Experimental: Solriamfetol * Up to 52 weeks in the combined open-label and open-label return segments; * Up to 24 weeks in the double-blind randomized withdrawal segment

  • PlaceboPlacebo, for comparison

    Up to 24 weeks in the double-blind randomized withdrawal segment

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
An Open-Label and Double-Blind, Randomized Withdrawal Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Adults With Binge Eating Disorder
Fit questions
Built from NCT06878976, who can take part
Record updated
6 November 2026