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New pill shows promise for Long-Term control of binge eating

NCT ID NCT06878976

Disease control Sponsor: Axsome Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 12, 2026 · Updated 3 times

Summary

This Phase 3 study tests the long-term safety and effectiveness of the drug solriamfetol in 300 adults with binge eating disorder. Participants take a daily pill (75, 150, or 300 mg) and are monitored for side effects and changes in binge eating. The study is open-label, meaning everyone knows they are getting the drug, and only includes people who completed a prior related study.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Solriamfetol (75 mg, 150 mg, or 300 mg taken once daily)
What this could lead to
If successful, this could provide a long-term medication option to help control binge eating episodes in adults with binge eating disorder.
What could go wrong
This is an open-label study (no placebo), so results may be biased. It only includes people who completed a prior study, so findings may not apply to all patients. Long-term side effects are still being evaluated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 236 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 56 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Completion of the treatment period in Study SOL-BED-301. Exclusion Criteria: * Unable to comply with study procedures. * Medically inappropriate for study participation in the opinion of the investigator.

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Conditions

The condition(s) this trial relates to.

binge eating disorder Binge-Eating Disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Binge-eating disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    33 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Clinical Research Site

    Encino, California, 91316, United States

  • Clinical Research Site

    Long Beach, California, 90806, United States

  • Clinical Research Site

    Santa Ana, California, 92705, United States

  • Clinical Research Site

    Walnut Creek, California, 94596, United States

  • Clinical Research Site

    West Covina, California, 91790, United States

  • Clinical Research Site

    Cromwell, Connecticut, 06416, United States

  • Clinical Research Site

    Fort Myers, Florida, 33912, United States

  • Clinical Research Site

    Jacksonville, Florida, 32256, United States

  • Clinical Research Site

    Lauderhill, Florida, 33319, United States

  • Clinical Research Site

    Miami, Florida, 33145, United States

  • Clinical Research Site

    Miami, Florida, 33176, United States

  • Clinical Research Site

    Miami Lakes, Florida, 33016, United States

  • Clinical Research Site

    Orlando, Florida, 32801, United States

  • Clinical Research Site

    Marietta, Georgia, 30060, United States

  • Clinical Research Site

    Overland Park, Kansas, 66210, United States

  • Clinical Research Site

    Boston, Massachusetts, 02131, United States

  • Clinical Research Site

    Saint Charles, Missouri, 63304, United States

  • Clinical Research Site

    Cherry Hill, New Jersey, 08002, United States

  • Clinical Research Site

    Mount Kisco, New York, 10549, United States

  • Clinical Research Site

    New York, New York, 10128, United States

  • Clinical Research Site

    Raleigh, North Carolina, 27607, United States

  • Clinical Research Site

    Cincinnati, Ohio, 45215, United States

  • Clinical Research Site

    Mason, Ohio, 45040, United States

  • Clinical Research Site

    Middleburg Heights, Ohio, 44130, United States

  • Clinical Research Site

    North Canton, Ohio, 44720, United States

  • Clinical Research Site

    Portland, Oregon, 97210, United States

  • Clinical Research Site

    Allentown, Pennsylvania, 18103, United States

  • Clinical Research Site

    North Charleston, South Carolina, 29405, United States

  • Clinical Research Site

    Memphis, Tennessee, 38119, United States

  • Clinical Research Site

    Austin, Texas, 78731, United States

  • Clinical Research Site

    Austin, Texas, 78737, United States

  • Clinical Research Site

    Dallas, Texas, 75251, United States

  • Clinical Research Site

    San Antonio, Texas, 78229, United States

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