FibromyalgiaPhase 3FORWARDNCT07398417
Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design
A Phase 3 study testing AXS-14 (Esreboxetine) in people with Fibromyalgia, run by Axsome Therapeutics, Inc. at 53 sites in United States.
Trial 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. 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?
- Yes, some participants may receive a placebo
- How many people
- 620 participants
- Where
- 53 sitesUnited States
- Study dates
- 14 Jan 2026to Mar 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- 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.
Trial locations and contacts
53 sites in 1 country. Contact the study team or a site near you to ask about taking part.
53 sites in 1 country
United States53 sites, 53 recruiting
- Recruiting
Clinical Research Site
Anaheim, California, 92801
- Recruiting
Clinical Research Site
Atlanta, Georgia, 30328
- Recruiting
Clinical Research Site
Atlanta, Georgia, 30329
- Recruiting
Clinical Research Site
Austin, Texas, 78731
- Recruiting
Clinical Research Site
Austin, Texas, 78737
- Recruiting
Clinical Research Site
Boston, Massachusetts, 02131
- Recruiting
Clinical Research Site
Brooklyn, New York, 11235
- Recruiting
Clinical Research Site
Chicago, Illinois, 60634
- Recruiting
Clinical Research Site
Cranston, Rhode Island, 02920
- Recruiting
Clinical Research Site
Cromwell, Connecticut, 06416
- Recruiting
Clinical Research Site
Dallas, Texas, 75251
- Recruiting
Clinical Research Site
Duncansville, Pennsylvania, 16635
- Recruiting
Clinical Research Site
Glendale, Arizona, 85308
- Recruiting
Clinical Research Site
Hartsdale, New York, 10530
- Recruiting
Clinical Research Site
Hazelwood, Missouri, 63042
- Recruiting
Houston
High Point, North Carolina, 27260
- Recruiting
Clinical Research Site
Hollywood, Florida, 33021
- Recruiting
Clinical Research Site
Houston, Texas, 77089
- Recruiting
Clinical Research Site
Huber Heights, Ohio, 45424
- Recruiting
Clinical Research Site
Jacksonville, Florida, 32256
- Recruiting
Clinical Research Site
Kansas City, Kansas, 66160
- Recruiting
Clinical Research Site
Knoxville, Tennessee, 37909
- Recruiting
Clinical Research Site
Lakeland, Florida, 33803
- Recruiting
Clinical Research Site
Las Vegas, Nevada, 89102
- Recruiting
Clinical Research Site
Little Rock, Arkansas, 72211
- Recruiting
Clinical Research Site
Louisville, Kentucky, 40205
- Recruiting
Clinical Research Site
Maitland, Florida, 32751
- Recruiting
Clinical Research Site
Marietta, Georgia, 30060
- Recruiting
Clinical Research Site
Memphis, Tennessee, 38119
- Recruiting
Clinical Research Site
Milford, Ohio, 45150
- Recruiting
Clinical Research Site
Norcross, Georgia, 30092
- Recruiting
Clinical Research Site
Oceanside, California, 92056
- Recruiting
Clinical Research Site
Orlando, Florida, 32801
- Recruiting
Clinical Research Site
Orlando, Florida, 32832
- Recruiting
Clinical Research Site
Overland Park, Kansas, 66209
- Recruiting
Clinical Research Site
Overland Park, Kansas, 66212
- Recruiting
Clinical Research Site
Phoenix, Arizona, 85032
- Recruiting
Clinical Research Site
Prairieville, Louisiana, 70769
- Recruiting
Clinical Research Site
Prosper, Texas, 75078
- Recruiting
Clinical Research Site
Redlands, California, 92374
- Recruiting
Clinical Research Site
Sacramento, California, 95821
- Recruiting
Clinical Research Site
San Antonio, Texas, 78240
- Recruiting
Clinical Research Site
Santa Ana, California, 92705
- Recruiting
Clinical Research Site
Springfield, Missouri, 65807
- Recruiting
Clinical Research Site
Tampa, Florida, 33634
- Recruiting
Clinical Research Site
The Villages, Florida, 32159
- Recruiting
Clinical Research Site
The Woodlands, Texas, 77832
- Recruiting
Clinical Research Site
Tinley Park, Illinois, 60477
- Recruiting
Clinical Research Site
Town and Country, Missouri, 63017
- Recruiting
Clinical Research Site
Tucson, Arizona, 85704
- Recruiting
Clinical Research Site
Tulsa, Oklahoma, 74133
- Recruiting
Clinical Research Site
Watertown, Massachusetts, 02472
- Recruiting
Clinical Research Site
Williamsville, New York, 14221
About this study
Official title: A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Assess the Efficacy and Safety of AXS-14 in the Management of Fibromyalgia
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.
Read the detailed description
This study is a multi-center trial consisting of a 12-week open-label treatment period (OLP), followed by a 12-week double-blind, placebo-controlled, randomized withdrawal period (DBRWP). During the OLP, subjects receive open-label AXS-14. Subjects achieving treatment response will be randomized into the DBRWP in a 1:1 ratio to either continue on AXS-14 or switch to placebo for up to 12 weeks or until a loss of therapeutic response occurs.
- Conditions
- Fibromyalgia
- Being tested
- AXS-14 (Esreboxetine), Placebo
- 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 once daily
PlaceboDrug
Placebo tablets taken once daily
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: AXS-14 (Esreboxetine) |
| Placebo | Placebo comparator | • Up to 12 weeks in the randomized double-blind period (if applicable) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from randomization to loss of therapeutic response
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start14 Jan 2026
- Primary completionMar 2028 (estimated)
- Study completionMar 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 620 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
- NCT07398417
- Sponsor's protocol ID
- AXS-14-FM-301
- Acronym
- FORWARD
- Status last verified
- Sep 2026
- First submitted
- 4 Feb 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Assess the Efficacy and Safety of AXS-14 in the Management of Fibromyalgia
- ClinicalTrials.gov ID
- NCT07398417
- Acronym / sponsor ID
- FORWARD / AXS-14-FM-301
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Central Sensitization, Allodynia, Hyperalgesia, Hypersensitivity to sensory stimuli, Inhibitor of the norepinephrine transporter (NET), Esreboxetine, AXS-14
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 620 participants (estimated)
- Lead sponsor
- Axsome Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Jan 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a multi-center trial consisting of a 12-week open-label treatment period (OLP), followed by a 12-week double-blind, placebo-controlled, randomized withdrawal period (DBRWP). During the OLP, subjects receive open-label AXS-14. Subjects achieving treatment response will be randomized into the DBRWP in a 1:1 ratio to either continue on AXS-14 or switch to placebo for up to 12 weeks or until a loss of therapeutic response occurs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AXS-14 (esreboxetine) | Experimental | Drug: 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 | Placebo comparator | Drug: Placebo• Up to 12 weeks in the randomized double-blind period (if applicable) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AXS-14 (Esreboxetine)AXS-14 tablets taken once daily | Drug | AXS-14 (esreboxetine) |
| PlaceboPlacebo tablets taken once daily | Drug | Placebo |
Primary outcome
Time from randomization to loss of therapeutic response
Time frame: 12 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Axsome Therapeutics WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
53 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AXS-14 (Esreboxetine) in people with Fibromyalgia, run by Axsome Therapeutics, Inc. at 53 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Director (212-332-5061, AXS-14-FM-301@axsome.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from randomization to loss of therapeutic response (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.