Clinical trial NCT06413433: Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol
Official title: A Phase 3, Randomized, Double-blind, Placebo-Controlled Trial of Solriamfetol in Adults With Binge Eating Disorder (BED)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
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
Lead sponsor: Axsome Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-05-14
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

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.

Primary outcomes:
measure: Change from Baseline to Week 12 in number of binge eating episodes
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Encino
country: United States
facility: Clinical Research Site
state: California
city: Garden Grove
country: United States
facility: Clinical Research Site
state: California
city: Long Beach
country: United States
facility: Clinical Research Site
state: California
city: Newport Beach
country: United States
facility: Clinical Research Site
state: California
city: San Diego
country: United States
facility: Clinical Research Site
state: California
city: Santa Ana
country: United States
facility: Clinical Research Site
state: California
city: Walnut Creek
country: United States
facility: Clinical Research Site
state: California
city: Colorado Springs
country: United States
facility: Clinical Research Site
state: Colorado
city: Cromwell
country: United States
facility: Clinical Research Site
state: Connecticut
city: Clermont
country: United States
facility: Clinical Research Site
state: Florida
city: Fort Myers
country: United States
facility: Clinical Research Site
state: Florida
city: Hialeah
country: United States
facility: Clinical Research Site
state: Florida
city: Jacksonville
country: United States
facility: Clinical Research Site
state: Florida
city: Lauderhill
country: United States
facility: Clinical Research Site
state: Florida
city: Miami Lakes
country: United States
facility: Clinical Research Site
state: Florida
city: Miami
country: United States
facility: Clinical Research Site
state: Florida
city: Orlando
country: United States
facility: Clinical Research Site
state: Florida
city: Orlando
country: United States
facility: Clinical Research Site
state: Florida
city: Marietta
country: United States
facility: Clinical Research Site
state: Georgia
city: Overland Park
country: United States
facility: Clinical Research Site
state: Kansas
city: Boston
country: United States
facility: Clinical Research Site
state: Massachusetts
city: Methuen
country: United States
facility: Clinical Research Site
state: Massachusetts
city: Saint Charles
country: United States
facility: Clinical Research Site
state: Missouri
city: Cherry Hill
country: United States
facility: Clinical Research Site
state: New Jersey
city: Princeton
country: United States
facility: Clinical Research Site
state: New Jersey
city: Mount Kisco
country: United States
facility: Clinical Research Site
state: New York
city: New York
country: United States
facility: Clinical Research Site
state: New York
city: Raleigh
country: United States
facility: Clinical Research Site
state: North Carolina
city: Cincinnati
country: United States
facility: Clinical Research Site
state: Ohio
city: Mason
country: United States
facility: Clinical Research Site
state: Ohio
city: Middleburg Heights
country: United States
facility: Clinical Research Site
state: Ohio
city: North Canton
country: United States
facility: Clinical Research Site
state: Ohio
city: Portland
country: United States
facility: Clinical Research Site
state: Oregon
city: Allentown
country: United States
facility: Clinical Research Site
state: Pennsylvania
city: Media
country: United States
facility: Clinical Research Site
state: Pennsylvania
city: Greenville
country: United States
facility: Clinical Research Site
state: South Carolina
city: North Charleston
country: United States
facility: Clinical Research Site
state: South Carolina
city: Memphis
country: United States
facility: Clinical Research Site
state: Tennessee
city: Austin
country: United States
facility: Clinical Research Site
state: Texas
city: Austin
country: United States
facility: Clinical Research Site
state: Texas
city: Dallas
country: United States
facility: Clinical Research Site
state: Texas
city: San Antonio
country: United States
facility: Clinical Research Site
state: Texas
city: Draper
country: United States
facility: Clinical Research Site
state: Utah
Study officials:
References: