Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia

Part of paid clinical trials in Santa Ana, California.

Sponsor
Axsome Therapeutics, Inc.
Study ID
NCT07637162
Phase
PHASE3
Status
Enrolling By Invitation

Conditions

  • Fibromyalgia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AXS-14 (esreboxetine) — DRUG
    AXS-14 tablets taken twice daily.

Study Details

This is a Phase 3, multi-center, 52-week, open-label trial to evaluate the long-term safety and efficacy of AXS-14 in the management of fibromyalgia.

Key Dates

Start date
Apr 29, 2026
Status verified
Jun 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

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

Arms

  • Experimental: AXS-14 (esreboxetine)
    Up to 52 weeks.

Primary Outcome Measure

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

Locations (8)

FacilityCityStateZIPSite coordinators
Clinical Research SiteSanta AnaCalifornia92705-
Clinical Research SiteJacksonvilleFlorida32256-
Clinical Research SiteOrlandoFlorida32801-
Clinical Research SiteTampaFlorida33634-
Clinical Research SiteAtlantaGeorgia30329-
Clinical Research SiteLouisvilleKentucky40205-
Clinical Research SiteTulsaOklahoma74133-
Clinical Research SiteCharlestonSouth Carolina29407-

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