Open-Label Safety Study of Solriamfetol in Subjects With Binge Eating Disorder

Axsome Therapeutics

Status and phase: Invitation-only; Phase 3

Conditions: Binge-Eating Disorder

Treatments: Drug: Solriamfetol 75mg, 150 mg, or 300 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT06878976

SOL-BED-303

Details and patient eligibility

About

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

Full description

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 56 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

Solriamfetol

Experimental group

Description:

Up to 52 weeks.

Treatment:

Drug: Solriamfetol 75mg, 150 mg, or 300 mg