Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia

June 4, 2026 updated by: Axsome Therapeutics, Inc.

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Ana, California, United States, 92705
        • Clinical Research Site
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Clinical Research Site
      • Orlando, Florida, United States, 32801
        • Clinical Research Site
      • Tampa, Florida, United States, 33634
        • Clinical Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Clinical Research Site
    • Kentucky
      • Louisville, Kentucky, United States, 40205
        • Clinical Research Site
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74133
        • Clinical Research Site
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Clinical Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AXS-14 (esreboxetine)
Up to 52 weeks.
Drug: AXS-14 (esreboxetine)
AXS-14 tablets taken twice daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term Safety
Time Frame: Up to 52 weeks.
Incidence of treatment-emergent adverse events following dosing with AXS-14
Up to 52 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Axsome Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

June 4, 2026

First Submitted That Met QC Criteria

June 4, 2026

First Posted (Actual)

June 9, 2026

Study Record Updates

Last Update Posted (Actual)

June 9, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AXS-14-FM-302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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