Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
An Open-Label Study to Assess the Long-Term Safety and Efficacy of AXS-14 in the Management of Fibromyalgia
1 other identifier
interventional
300
1 country
18
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2026
18 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
April 29, 2026
CompletedFirst Submitted
Initial submission to the registry
June 4, 2026
CompletedFirst Posted
Study publicly available on registry
June 9, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2028
July 24, 2026
July 1, 2026
2 years
June 4, 2026
July 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Long-term Safety
Incidence of treatment-emergent adverse events following dosing with AXS-14
Up to 52 weeks.
Study Arms (1)
AXS-14 (esreboxetine)
EXPERIMENTALUp to 52 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Participation in AXS-14-FM-301.
You may not qualify if:
- 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 (18)
Clinical Research Site
Arkansas City, Arkansas, 72211, 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
Jacksonville, Florida, 32256, United States
Clinical Research Site
Orlando, Florida, 32801, United States
Clinical Research Site
Tampa, Florida, 33634, United States
Clinical Research Site
Atlanta, Georgia, 30329, United States
Clinical Research Site
Norcross, Georgia, 30092, United States
Clinical Research Site
Chicago, Illinois, 60634, United States
Clinical Research Site
Overland Park, Kansas, 66209, United States
Clinical Research Site
Louisville, Kentucky, 40205, United States
Clinical Research Site
Boston, Massachusetts, 02131, United States
Clinical Research Site
Brooklyn, New York, 11235, United States
Clinical Research Site
Tulsa, Oklahoma, 74133, United States
Clinical Research Site
Charleston, South Carolina, 29407, United States
Clinical Research Site
Knoxville, Tennessee, 37909, United States
Clinical Research Site
Memphis, Tennessee, 38119, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2026
First Posted
June 9, 2026
Study Start
April 29, 2026
Primary Completion (Estimated)
May 1, 2028
Study Completion (Estimated)
May 1, 2028
Last Updated
July 24, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share