A Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Subjects With Binge Eating Disorder

An Open-Label and Double-Blind, Randomized Withdrawal Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Adults With Binge Eating Disorder

Status

Enrolling by invitation

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06878976

Enrollment

236

Registered

2025-03-17

Start date

2025-02-20

Completion date

2027-12-01

Last updated

2026-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Brief summary

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

Detailed description

This study includes three segments: Open-Label (OL), Double-Blind Randomized Withdrawal (RW), and Open-Label Return (OLR). Eligible subjects will have completed the SOL-BED-301 (ENGAGE) study. All subjects will receive open-label solriamfetol for up to 52 weeks during the OL segment. Subjects who enter the RW segment will be randomized 1:1 to either continue solriamfetol or switch to placebo for up to 24 weeks of double-blind treatment, followed by a return to open-label solriamfetol in the OLR segment. The overall duration of study treatment is up to 77 weeks.

Interventions

DRUGSolriamfetol

Solriamfetol tablets, taken once daily

DRUGPlacebo

Placebo tablets, taken once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 56 Years

Healthy volunteers

Inclusion criteria

* Completion of the treatment period in Study SOL-BED-301.

Exclusion criteria

* Unable to comply with study procedures. * Medically inappropriate for study participation in the opinion of the investigator.

Design outcomes

Primary

Measure	Time frame
Time from randomization to relapse of binge eating in the RW segment	Up to 24 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 12, 2026