A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Assess the Efficacy and Safety of AXS-14 in the Management of Fibromyalgia
Status: Recruiting
Location: See all (16) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Has a primary diagnosis of fibromyalgia based on the 2016 ACR diagnostic criteria.
• Male or female, ≥18 years of age.
• Provides written informed consent to participate in the study before conducting any study procedures.
Locations
United States
Arkansas
Clinical Research Site
RECRUITING
Little Rock
California
Clinical Research Site
RECRUITING
Santa Ana
Connecticut
Clinical Research Site
RECRUITING
Cromwell
Florida
Clinical Research Site
RECRUITING
Jacksonville
Clinical Research Site
RECRUITING
Orlando
Clinical Research Site
RECRUITING
Tampa
Georgia
Clinical Research Site
RECRUITING
Atlanta
Kansas
Clinical Research Site
RECRUITING
Overland Park
Kentucky
Clinical Research Site
RECRUITING
Louisville
Louisiana
Clinical Research Site
RECRUITING
Prairieville
Missouri
Clinical Research Site
RECRUITING
Springfield
Clinical Research Site
RECRUITING
Town And Country
Oklahoma
Clinical Research Site
RECRUITING
Tulsa
South Carolina
Clinical Research Site
RECRUITING
Charleston
Tennessee
Clinical Research Site
RECRUITING
Memphis
Texas
Clinical Research Site
RECRUITING
Prosper
Contact Information
Primary
Study Director
AXS-14-FM-301@axsome.com
212-332-5061
Time Frame
Start Date: 2026-01-14
Estimated Completion Date: 2028-03
Participants
Target number of participants: 620
Treatments
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)
Related Therapeutic Areas
Sponsors
Leads: Axsome Therapeutics, Inc.