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

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Key information

Conditions

Fibromyalgia Hyperalgesia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pathological Conditions, Signs and Symptoms Rheumatic Diseases Sensation Disorders Signs and Symptoms Somatosensory Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Research Site, Arkansas City, Arkansas, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AXS-14 (esreboxetine)

Drug

AXS-14 tablets taken twice daily.

Primary outcomes

Long-term Safety

Time frame: Up to 52 weeks.

Incidence of treatment-emergent adverse events following dosing with AXS-14

Sponsors and collaborators

Lead sponsor

Axsome Therapeutics, Inc.

Industry

Registry information

Official study title

An Open-Label Study to Assess the Long-Term Safety and Efficacy of AXS-14 in the Management of Fibromyalgia

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Jun 9, 2026
Registry last updated: Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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