Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design
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A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Assess the Efficacy and Safety of AXS-14 in the Management of Fibromyalgia
1 other identifier
interventional
620
1 country
51
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2026
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 14, 2026
CompletedFirst Submitted
Initial submission to the registry
February 4, 2026
CompletedFirst Posted
Study publicly available on registry
February 9, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
July 24, 2026
July 1, 2026
2.1 years
February 4, 2026
July 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time from randomization to loss of therapeutic response
12 Weeks
Study Arms (2)
AXS-14 (esreboxetine)
EXPERIMENTAL* Up to 12 weeks in the open-label period; * Up to 12 weeks in the randomized double-blind period (if applicable)
Placebo
PLACEBO COMPARATOR• Up to 12 weeks in the randomized double-blind period (if applicable)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Previous participation in a clinical trial with reboxetine or esreboxetine or currently receiving treatment with reboxetine for any condition.
- Unable to comply with study procedures.
- Medically inappropriate for study participation in the opinion of the investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
Clinical Research Site
Glendale, Arizona, 85308, United States
Clinical Research Site
Phoenix, Arizona, 85032, United States
Clinical Research Site
Tucson, Arizona, 85704, United States
Clinical Research Site
Little Rock, Arkansas, 72211, United States
Clinical Research Site
Anaheim, California, 92801, United States
Clinical Research Site
Oceanside, California, 92056, United States
Clinical Research Site
Redlands, California, 92374, United States
Clinical Research Site
Sacramento, California, 95821, United States
Clinical Research Site
Santa Ana, California, 92705, United States
Clinical Research Site
Cromwell, Connecticut, 06416, United States
Clinical Research Site
Hollywood, Florida, 33021, United States
Clinical Research Site
Jacksonville, Florida, 32256, United States
Clinical Research Site
Lakeland, Florida, 33803, United States
Clinical Research Site
Maitland, Florida, 32751, United States
Clinical Research Site
Orlando, Florida, 32801, United States
Clinical Research Site
Orlando, Florida, 32832, United States
Clinical Research Site
Tampa, Florida, 33634, United States
Clinical Research Site
The Villages, Florida, 32159, United States
Clinical Research Site
Atlanta, Georgia, 30328, United States
Clinical Research Site
Atlanta, Georgia, 30329, United States
Clinical Research Site
Marietta, Georgia, 30060, United States
Clinical Research Site
Norcross, Georgia, 30092, United States
Clinical Research Site
Chicago, Illinois, 60634, United States
Clinical Research Site
Tinley Park, Illinois, 60477, United States
Clinical Research Site
Overland Park, Kansas, 66209, United States
Clinical Research Site
Overland Park, Kansas, 66210, United States
Clinical Research Site
Louisville, Kentucky, 40205, United States
Clinical Research Site
Prairieville, Louisiana, 70769, United States
Clinical Research Site
Boston, Massachusetts, 02131, United States
Clinical Research Site
Watertown, Massachusetts, 02472, United States
Clinical Research Site
Hazelwood, Missouri, 63042, United States
Clinical Research Site
Springfield, Missouri, 65807, United States
Clinical Research Site
Town and Country, Missouri, 63017, United States
Clinical Research Site
Las Vegas, Nevada, 89102, United States
Clinical Research Site
Brooklyn, New York, 11235, United States
Clinical Research Site
Hartsdale, New York, 10530, United States
Clinical Research Site
Williamsville, New York, 14221, United States
Houston
High Point, North Carolina, 27260, United States
Clinical Research Site
Huber Heights, Ohio, 45424, United States
Clinical Research Site
Milford, Ohio, 45150, United States
Clinical Research Site
Tulsa, Oklahoma, 74133, United States
Clinical Research Site
Duncansville, Pennsylvania, 16635, United States
Clinical Research Site
Cranston, Rhode Island, 02920, United States
Clinical Research Site
Knoxville, Tennessee, 37909, United States
Clinical Research Site
Memphis, Tennessee, 38119, United States
Clinical Research Site
Austin, Texas, 78731, United States
Clinical Research Site
Austin, Texas, 78737, United States
Clinical Research Site
Dallas, Texas, 75251, United States
Clinical Research Site
Houston, Texas, 77089, United States
Clinical Research Site
Prosper, Texas, 75078, United States
Clinical Research Site
San Antonio, Texas, 78240, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2026
First Posted
February 9, 2026
Study Start
January 14, 2026
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
March 1, 2028
Last Updated
July 24, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share