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NCT Number: NCT07398417

Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design

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.

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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, Glendale, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

AXS-14 (esreboxetine)

Drug

AXS-14 tablets taken once daily

Placebo

Drug

Placebo tablets taken once daily

Primary outcomes

  1. Time from randomization to loss of therapeutic response

    Time frame: 12 Weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Study Director

CONTACT

[email protected]

212-332-5061

Sponsors and collaborators

Lead sponsor

Axsome Therapeutics, Inc.

Industry

Registry information

Official study title

A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Assess the Efficacy and Safety of AXS-14 in the Management of Fibromyalgia

Acronym: FORWARD

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 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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