Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Axsome Therapeutics, Inc.
Study ID
NCT07398417
Phase
PHASE3
Status
Recruiting
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Conditions

  • Fibromyalgia

Eligibility Criteria

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

Interventions

  • AXS-14 (Esreboxetine) — DRUG
    AXS-14 tablets taken once daily
  • Placebo — DRUG
    Placebo tablets taken once daily

Study Details

The study is a Phase 3, double-blind, placebo-controlled, randomized withdrawal study to assess the efficacy and safety of AXS-14 in the management of fibromyalgia.

Key Dates

Start date
Jan 14, 2026
Status verified
Feb 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
620 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AXS-14 (esreboxetine)
    * Up to 12 weeks in the open-label period; * Up to 12 weeks in the randomized double-blind period (if applicable)
  • Placebo Comparator: Placebo
    • Up to 12 weeks in the randomized double-blind period (if applicable)

Primary Outcome Measure

Time from randomization to loss of therapeutic response [ Time Frame: 12 Weeks ]

Central Contacts

Locations (16)

FacilityCityStateZIPSite coordinators
Clinical Research SiteLittle RockArkansas72211-
Clinical Research SiteSanta AnaCalifornia92705-
Clinical Research SiteCromwellConnecticut06416-
Clinical Research SiteJacksonvilleFlorida32256-
Clinical Research SiteOrlandoFlorida32801-
Clinical Research SiteTampaFlorida33634-
Clinical Research SiteAtlantaGeorgia30329-
Clinical Research SiteOverland ParkKansas66209-
Clinical Research SiteLouisvilleKentucky40205-
Clinical Research SitePrairievilleLouisiana70769-
Clinical Research SiteSpringfieldMissouri65807-
Clinical Research SiteTown and CountryMissouri63017-
Clinical Research SiteTulsaOklahoma74133-
Clinical Research SiteCharlestonSouth Carolina29407-
Clinical Research SiteMemphisTennessee38119-
Clinical Research SiteProsperTexas75078-

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