NCT06878976

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
7mo left

Started Feb 2025

Geographic Reach
1 country

31 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Feb 2025Dec 2026

Study Start

First participant enrolled

February 20, 2025

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 17, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

1.8 years

First QC Date

March 14, 2025

Last Update Submit

November 20, 2025

Conditions

Binge-Eating Disorder

Keywords

Binge eating disorderBEDSolriamfetolSunosiAxsomeNon-stimulant therapyDopamine norepinephrine reuptake inhibitorTrace amine-associated receptor 1 (TAAR1) agonist

Outcome Measures

Primary Outcomes (1)

  • Long-term Safety

    Incidence of treatment-emergent adverse events following dosing with solriamfetol

    Up to 52 weeks.

Study Arms (1)

Solriamfetol

EXPERIMENTAL

Up to 52 weeks.

Drug: Solriamfetol 75mg, 150 mg, or 300 mg

Interventions

Solriamfetol 75mg, 150 mg, or 300 mgDRUG

Taken once daily.

Solriamfetol

Eligibility Criteria

Age18 Years - 56 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Completion of the treatment period in Study SOL-BED-301.
  • Able to comply with study procedures.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (31)

Clinical Research Site

Encino, California, 91316, United States

Location

Clinical Research Site

Long Beach, California, 90806, United States

Location

Clinical Research Site

Santa Ana, California, 92705, United States

Location

Clinical Research Site

Walnut Creek, California, 94596, United States

Location

Clinical Research Site

West Covina, California, 91790, United States

Location

Clinical Research Site

Cromwell, Connecticut, 06416, United States

Location

Clinical Research Site

Fort Myers, Florida, 33912, United States

Location

Clinical Research Site

Hialeah, Florida, 33012, United States

Location

Clinical Research Site

Jacksonville, Florida, 32256, United States

Location

Clinical Research Site

Lauderhill, Florida, 33319, United States

Location

Clinical Research Site

Miami, Florida, 33145, United States

Location

Clinical Research Site

Miami, Florida, 33176, United States

Location

Clinical Research Site

Orlando, Florida, 32801, United States

Location

Clinical Research Site

Marietta, Georgia, 30060, United States

Location

Clinical Research Site

Overland Park, Kansas, 66210, United States

Location

Clinical Research Site

Boston, Massachusetts, 02131, United States

Location

Clinical Research Site

Saint Charles, Missouri, 63304, United States

Location

Clinical Research Site

Cherry Hill, New Jersey, 08002, United States

Location

Clinical Research Site

Mount Kisco, New York, 10549, United States

Location

Clinical Research Site

New York, New York, 10128, United States

Location

Clinical Research Site

Raleigh, North Carolina, 27607, United States

Location

Clinical Research Site

Cincinnati, Ohio, 45215, United States

Location

Clinical Research Site

Mason, Ohio, 45040, United States

Location

Clinical Research Site

North Canton, Ohio, 44720, United States

Location

Clinical Research Site

Portland, Oregon, 97210, United States

Location

Clinical Research Site

North Charleston, South Carolina, 29405, United States

Location

Clinical Research Site

Memphis, Tennessee, 38119, United States

Location

Clinical Research Site

Austin, Texas, 78731, United States

Location

Clinical Research Site

Austin, Texas, 78737, United States

Location

Clinical Research Site

Dallas, Texas, 75251, United States

Location

Clinical Research Site

San Antonio, Texas, 78229, United States

Location

Related Links

MeSH Terms

Conditions

Binge-Eating Disorder

Interventions

solriamfetol

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2025

First Posted

March 17, 2025

Study Start

February 20, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

November 25, 2025

Record last verified: 2025-11

Locations

US(31)