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

NCT07637162 · Status: ENROLLING_BY_INVITATION · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-07-24

No results posted yet for this study

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.

Conditions

  • Fibromyalgia

Interventions

DRUG

AXS-14 (esreboxetine)

AXS-14 tablets taken twice daily.

Sponsors & Collaborators

  • Axsome Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-29
Primary Completion
2028-05-31
Completion
2028-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07637162 on ClinicalTrials.gov