NCT06413433 Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol
| NCT ID | NCT06413433 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Axsome Therapeutics, Inc. |
| Condition | Binge-Eating Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 450 participants |
| Start Date | 2024-04-26 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 450 participants in total. It began in 2024-04-26 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
ENGAGE (Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the efficacy and safety of solriamfetol for the treatment of binge eating disorder (BED) in adults.
Eligibility Criteria
Inclusion Criteria: * Primary diagnosis of BED according to DSM-5 criteria. * Provides written informed consent to participate in the study before the conduct of any study procedures. * Male or female, aged 18 to 55 inclusive. Exclusion Criteria: * Prior exposure to solriamfetol/Sunosi, through either a clinical study or prescription. * Unable to comply with study procedures. * Medically inappropriate for study participation in the opinion of the investigator.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06413433 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Binge-Eating Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06413433 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 450 participants.
Is NCT06413433 currently recruiting?
Yes, NCT06413433 is actively recruiting participants. Contact the research team at sol-bed-301@axsome.com for enrollment information.
Where is the NCT06413433 trial being conducted?
This trial is being conducted at Encino, United States, Garden Grove, United States, Long Beach, United States, Newport Beach, United States and 11 additional locations.
Who is sponsoring the NCT06413433 clinical trial?
NCT06413433 is sponsored by Axsome Therapeutics, Inc.. The trial plans to enroll 450 participants.