FibromyalgiaPhase 3NCT07637162
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
A Phase 3 study testing AXS-14 (esreboxetine) in people with Fibromyalgia, run by Axsome Therapeutics, Inc. at 35 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- AXS-14 (esreboxetine)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 35 sitesUnited States
- Study dates
- 29 Apr 2026to May 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participation in AXS-14-FM-301.
Who cannot join
- Unable to comply with study procedures.
- Medically inappropriate for study participation in the opinion of the Investigator.
Trial locations and contacts
35 sites in 1 country. Contact the study team or a site near you to ask about taking part.
35 sites in 1 country
United States35 sites
Clinical Research Site
Atlanta, Georgia, 30329
Clinical Research Site
Austin, Texas, 78737
Clinical Research Site
Boston, Massachusetts, 02131
Clinical Research Site
Brooklyn, New York, 11235
Clinical Research Site
Charleston, South Carolina, 29407
Clinical Research Site
Chicago, Illinois, 60634
Clinical Research Site
Cromwell, Connecticut, 06416
Clinical Research Site
Dallas, Texas, 75251
Clinical Research Site
Duncansville, Pennsylvania, 16635
Clinical Research Site
Hollywood, Florida, 33021
Clinical Research Site
Jacksonville, Florida, 32256
Clinical Research Site
Knoxville, Tennessee, 37909
Clinical Research Site
Lakeland, Florida, 33803
Clinical Research Site
Las Vegas, Nevada, 89102
Clinical Research Site
Little Rock, Arkansas, 72211
Clinical Research Site
Louisville, Kentucky, 40205
Clinical Research Site
Memphis, Tennessee, 38119
Clinical Research Site
Norcross, Georgia, 30092
Clinical Research Site
Oceanside, California, 92056
Clinical Research Site
Orlando, Florida, 32801
Clinical Research Site
Orlando, Florida, 32832
Clinical Research Site
Overland Park, Kansas, 66209
Clinical Research Site
Overland Park, Kansas, 66212
Clinical Research Site
Prairieville, Louisiana, 70769
Clinical Research Site
Prosper, Texas, 75078
Clinical Research Site
Redlands, California, 92374
Clinical Research Site
Sacramento, California, 95821
Clinical Research Site
Santa Ana, California, 92705
Clinical Research Site
Springfield, Missouri, 65807
Clinical Research Site
Tampa, Florida, 33634
Clinical Research Site
The Villages, Florida, 32159
Clinical Research Site
Town and Country, Missouri, 63017
Clinical Research Site
Tulsa, Oklahoma, 74133
Clinical Research Site
Watertown, Massachusetts, 02472
Clinical Research Site
Williamsville, New York, 14221
About this study
Official title: An Open-Label Study to Assess the Long-Term Safety and Efficacy of AXS-14 in the Management of Fibromyalgia
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.
Read the detailed description
Eligible subjects will have previously participated in the AXS-14-FM-301 (FORWARD) study. Subjects in this open-label extension trial will receive open-label AXS-14 for up to 52 weeks.
- Conditions
- Fibromyalgia
- Being tested
- AXS-14 (esreboxetine)
- Keywords
- Fibromyalgia, Central Sensitization, Allodynia, Hyperalgesia, Hypersensitivity to sensory stimuli, Inhibitor of the norepinephrine transporter (NET), Esreboxetine, AXS-14, Axsome, Norepinephrine reuptake inhibitor
- Medical subject headings
- Fibromyalgia, Hyperalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AXS-14 (esreboxetine)Drug
AXS-14 tablets taken twice daily.
| Study group | Role | What they receive |
|---|---|---|
| AXS-14 (esreboxetine) | Experimental | Up to 52 weeks. Receives: Drug: AXS-14 (esreboxetine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term Safety
Incidence of treatment-emergent adverse events following dosing with AXS-14
Measured: Up to 52 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start29 Apr 2026
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Axsome Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07637162
- Sponsor's protocol ID
- AXS-14-FM-302
- Status last verified
- Oct 2026
- First submitted
- 4 Jun 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No