Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol (ENGAGE)

Axsome Therapeutics

Status and phase: Enrolling; Phase 3

Conditions: Binge-Eating Disorder

Treatments: Drug: Placebo; Drug: Solriamfetol 300 mg; Drug: Solriamfetol 150 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT06413433

SOL-BED-301

Details and patient eligibility

About

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.

Full description

Eligible subjects must have a diagnosis of BED according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. Subjects will be randomized in a 1:1:1 ratio to receive solriamfetol (150 or 300 mg) or placebo, once daily for 12 weeks.

Enrollment: 450 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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450 participants in 3 patient groups, including a placebo group

Solriamfetol 150 mg

Experimental group

Description:

Up to 12 weeks

Treatment:

Drug: Solriamfetol 150 mg

Solriamfetol 300 mg

Experimental group

Description:

Up to 12 weeks

Treatment:

Drug: Solriamfetol 300 mg

Placebo

Placebo Comparator group

Description:

Up to 12 weeks

Treatment:

Drug: Placebo