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

Conditions

• Binge-Eating Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - 55 Years

Healthy Volunteers

Not accepted

Interventions

• Solriamfetol 150 mg — DRUG
  Solriamfetol tablets, taken once daily
• Solriamfetol 300 mg — DRUG
  Solriamfetol tablets, taken once daily
• Placebo — DRUG
  Placebo tablets, taken once daily

Study Details

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.

Key Dates

Start date

Apr 26, 2024

Status verified

Nov 2025

Primary completion

Dec 31, 2025

Completion

Dec 31, 2025

Study Design

Enrollment

450 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Solriamfetol 150 mg
  Up to 12 weeks
• Experimental: Solriamfetol 300 mg
  Up to 12 weeks
• Placebo Comparator: Placebo
  Up to 12 weeks

Primary Outcome Measure

Change from Baseline to Week 12 in number of binge eating episodes [ Time Frame: 12 weeks ]

Central Contacts

• Study Director
  212-332-5061
  [email protected]

Locations (45)

Find similar trials in Encino, CA

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