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Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design
Sponsor: Axsome Therapeutics, Inc.
Summary
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.
Official title: A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Assess the Efficacy and Safety of AXS-14 in the Management of Fibromyalgia
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
620
Start Date
2026-01-14
Completion Date
2028-03
Last Updated
2026-02-09
Healthy Volunteers
No
Conditions
Interventions
AXS-14 (Esreboxetine)
AXS-14 tablets taken once daily
Placebo
Placebo tablets taken once daily
Locations (16)
Clinical Research Site
Little Rock, Arkansas, United States
Clinical Research Site
Santa Ana, California, United States
Clinical Research Site
Cromwell, Connecticut, United States
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Jacksonville, Florida, United States
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Orlando, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Overland Park, Kansas, United States
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Louisville, Kentucky, United States
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Prairieville, Louisiana, United States
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Springfield, Missouri, United States
Clinical Research Site
Town and Country, Missouri, United States
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Tulsa, Oklahoma, United States
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Charleston, South Carolina, United States
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Memphis, Tennessee, United States
Clinical Research Site
Prosper, Texas, United States