Clinical trial NCT06878976: Open-Label Safety Study of Solriamfetol in Subjects with Binge Eating Disorder
Official title: An Open-Label Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Adults with Binge Eating Disorder
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
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: 2025-03-17
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 56
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Long-term Safety
timeFrame: Up to 52 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Encino
country: United States
facility: Clinical Research Site
state: California
city: Walnut Creek
country: United States
facility: Clinical Research Site
state: California
city: Cromwell
country: United States
facility: Clinical Research Site
state: Connecticut
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: Miami
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: Saint Charles
country: United States
facility: Clinical Research Site
state: Missouri
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: North Canton
country: United States
facility: Clinical Research Site
state: Ohio
city: Memphis
country: United States
facility: Clinical Research Site
state: Tennessee
city: Austin
country: United States
facility: Clinical Research Site
state: Texas
city: Dallas
country: United States
facility: Clinical Research Site
state: Texas
Study officials:
References: