Binge-Eating DisorderPhase 3NCT06878976
A Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Subjects With Binge Eating Disorder
A Phase 3 study testing Solriamfetol in people with Binge-Eating Disorder, run by Axsome Therapeutics, Inc. at 33 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 56 years
- Conditions the study is for
- Binge-Eating Disorder
- What is being tested?
- Solriamfetol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 236 participants
- Where
- 33 sitesUnited States
- Study dates
- 20 Feb 2025to Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 56 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Completion of the treatment period in Study SOL-BED-301.
Who cannot join
- Unable to comply with study procedures.
- Medically inappropriate for study participation in the opinion of the investigator.
Trial locations and contacts
33 sites in 1 country. Contact the study team or a site near you to ask about taking part.
33 sites in 1 country
United States33 sites
Clinical Research Site
Allentown, Pennsylvania, 18103
Clinical Research Site
Austin, Texas, 78731
Clinical Research Site
Austin, Texas, 78737
Clinical Research Site
Boston, Massachusetts, 02131
Clinical Research Site
Cherry Hill, New Jersey, 08002
Clinical Research Site
Cincinnati, Ohio, 45215
Clinical Research Site
Cromwell, Connecticut, 06416
Clinical Research Site
Dallas, Texas, 75251
Clinical Research Site
Encino, California, 91316
Clinical Research Site
Fort Myers, Florida, 33912
Clinical Research Site
Jacksonville, Florida, 32256
Clinical Research Site
Lauderhill, Florida, 33319
Clinical Research Site
Long Beach, California, 90806
Clinical Research Site
Marietta, Georgia, 30060
Clinical Research Site
Mason, Ohio, 45040
Clinical Research Site
Memphis, Tennessee, 38119
Clinical Research Site
Miami, Florida, 33145
Clinical Research Site
Miami, Florida, 33176
Clinical Research Site
Miami Lakes, Florida, 33016
Clinical Research Site
Middleburg Heights, Ohio, 44130
Clinical Research Site
Mount Kisco, New York, 10549
Clinical Research Site
New York, New York, 10128
Clinical Research Site
North Canton, Ohio, 44720
Clinical Research Site
North Charleston, South Carolina, 29405
Clinical Research Site
Orlando, Florida, 32801
Clinical Research Site
Overland Park, Kansas, 66210
Clinical Research Site
Portland, Oregon, 97210
Clinical Research Site
Raleigh, North Carolina, 27607
Clinical Research Site
Saint Charles, Missouri, 63304
Clinical Research Site
San Antonio, Texas, 78229
Clinical Research Site
Santa Ana, California, 92705
Clinical Research Site
Walnut Creek, California, 94596
Clinical Research Site
West Covina, California, 91790
About this study
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
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.
Read the detailed description
This study includes three segments: Open-Label (OL), Double-Blind Randomized Withdrawal (RW), and Open-Label Return (OLR). Eligible subjects will have completed the SOL-BED-301 (ENGAGE) study. All subjects will receive open-label solriamfetol for up to 52 weeks during the OL segment. Subjects who enter the RW segment will be randomized 1:1 to either continue solriamfetol or switch to placebo for up to 24 weeks of double-blind treatment, followed by a return to open-label solriamfetol in the OLR segment. The overall duration of study treatment is up to 77 weeks.
- Conditions
- Binge-Eating Disorder
- Being tested
- Solriamfetol, Placebo
- Keywords
- Binge eating disorder, BED, Solriamfetol, Sunosi, Axsome, Non-stimulant therapy, Dopamine norepinephrine reuptake inhibitor, Trace amine-associated receptor 1 (TAAR1) agonist
- Medical subject headings
- Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SolriamfetolDrug
Solriamfetol tablets, taken once daily
PlaceboDrug
Placebo tablets, taken once daily
| Study group | Role | What they receive |
|---|---|---|
| Solriamfetol | Experimental | 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 Receives: Drug: Solriamfetol |
| Placebo | Placebo comparator | Up to 24 weeks in the double-blind randomized withdrawal segment Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from randomization to relapse of binge eating in the RW segment
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start20 Feb 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge-Eating DisorderStudies of the same condition, open and under way.
- More trials run by Axsome Therapeutics, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Axsome Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878976
- Sponsor's protocol ID
- SOL-BED-303
- Status last verified
- Aug 2026
- First submitted
- 14 Mar 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06878976
- Acronym / sponsor ID
- SOL-BED-303
- Conditions
- Binge-Eating Disorder
- Keywords
- Binge eating disorder, BED, Solriamfetol, Sunosi, Axsome, Non-stimulant therapy, Dopamine norepinephrine reuptake inhibitor, Trace amine-associated receptor 1 (TAAR1) agonist
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Axsome Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study includes three segments: Open-Label (OL), Double-Blind Randomized Withdrawal (RW), and Open-Label Return (OLR). Eligible subjects will have completed the SOL-BED-301 (ENGAGE) study. All subjects will receive open-label solriamfetol for up to 52 weeks during the OL segment. Subjects who enter the RW segment will be randomized 1:1 to either continue solriamfetol or switch to placebo for up to 24 weeks of double-blind treatment, followed by a return to open-label solriamfetol in the OLR segment. The overall duration of study treatment is up to 77 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Solriamfetol | Experimental | Drug: SolriamfetolExperimental: 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 |
| Placebo | Placebo comparator | Drug: PlaceboUp to 24 weeks in the double-blind randomized withdrawal segment |
Who may qualify
- Ages
- 18 to 56 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Completion of the treatment period in Study SOL-BED-301.
Key exclusion criteria (2 listed)
- Unable to comply with study procedures.
- Medically inappropriate for study participation in the opinion of the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SolriamfetolSolriamfetol tablets, taken once daily | Drug | Solriamfetol |
| PlaceboPlacebo tablets, taken once daily | Drug | Placebo |
Primary outcome
Time from randomization to relapse of binge eating in the RW segment
Time frame: Up to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Axsome Therapeutics WebsiteLink provided by the sponsor.
- SOL-BED-301 (ENGAGE) Study WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Solriamfetol in people with Binge-Eating Disorder, run by Axsome Therapeutics, Inc. at 33 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from randomization to relapse of binge eating in the RW segment (time frame: Up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.