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New fibromyalgia drug shows promise in Long-Term safety trial

NCT ID NCT07637162

Symptom relief Sponsor: Axsome Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This study tests the long-term safety and effectiveness of an experimental drug called AXS-14 for people with fibromyalgia, a condition causing widespread pain and fatigue. About 300 adults who previously took part in a related study will receive AXS-14 for 52 weeks. Researchers will monitor side effects to see if the drug is safe for extended use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participation in AXS-14-FM-301. Exclusion Criteria: * Unable to comply with study procedures. * Medically inappropriate for study participation in the opinion of the Investigator.

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Conditions

The condition(s) this trial relates to.

fibromyalgia Hyperalgesia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fibromyalgia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    31 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Clinical Research Site

    Little Rock, 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

    Hollywood, Florida, 33021, United States

  • Clinical Research Site

    Jacksonville, Florida, 32256, United States

  • Clinical Research Site

    Lakeland, Florida, 33803, 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

    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

    Overland Park, Kansas, 66212, 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

    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

    Williamsville, New York, 14221, United States

  • Clinical Research Site

    Tulsa, Oklahoma, 74133, United States

  • Clinical Research Site

    Duncansville, Pennsylvania, 16635, 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

  • Clinical Research Site

    Austin, Texas, 78737, United States

  • Clinical Research Site

    Dallas, Texas, 75251, United States

  • Clinical Research Site

    Prosper, Texas, 75078, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.