Open-Label Safety Study of Solriamfetol in Subjects With Binge Eating Disorder

Part of paid clinical trials in Encino, California.

Sponsor
Axsome Therapeutics, Inc.
Study ID
NCT06878976
Phase
PHASE3
Status
Enrolling By Invitation

Conditions

  • Binge-Eating Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 56 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Feb 20, 2025
Status verified
Nov 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
300 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Solriamfetol
    Up to 52 weeks.

Primary Outcome Measure

Long-term Safety [ Time Frame: Up to 52 weeks. ]

Locations (31)

FacilityCityStateZIPSite coordinators
Clinical Research SiteEncinoCalifornia91316-
Clinical Research SiteLong BeachCalifornia90806-
Clinical Research SiteSanta AnaCalifornia92705-
Clinical Research SiteWalnut CreekCalifornia94596-
Clinical Research SiteWest CovinaCalifornia91790-
Clinical Research SiteCromwellConnecticut06416-
Clinical Research SiteFort MyersFlorida33912-
Clinical Research SiteHialeahFlorida33012-
Clinical Research SiteJacksonvilleFlorida32256-
Clinical Research SiteLauderhillFlorida33319-
Clinical Research SiteMiamiFlorida33145-
Clinical Research SiteMiamiFlorida33176-
Clinical Research SiteOrlandoFlorida32801-
Clinical Research SiteMariettaGeorgia30060-
Clinical Research SiteOverland ParkKansas66210-
Clinical Research SiteBostonMassachusetts02131-
Clinical Research SiteSaint CharlesMissouri63304-
Clinical Research SiteCherry HillNew Jersey08002-
Clinical Research SiteMount KiscoNew York10549-
Clinical Research SiteNew YorkNew York10128-
Clinical Research SiteRaleighNorth Carolina27607-
Clinical Research SiteCincinnatiOhio45215-
Clinical Research SiteMasonOhio45040-
Clinical Research SiteNorth CantonOhio44720-
Clinical Research SitePortlandOregon97210-
Clinical Research SiteNorth CharlestonSouth Carolina29405-
Clinical Research SiteMemphisTennessee38119-
Clinical Research SiteAustinTexas78731-
Clinical Research SiteAustinTexas78737-
Clinical Research SiteDallasTexas75251-
Clinical Research SiteSan AntonioTexas78229-

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