RecruitingPhase 3NCT07398417

Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design

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


Sponsor

Axsome Therapeutics, Inc.

Enrollment

620 participants

Start Date

Jan 14, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called AXS-14 (Esreboxetine) and a drug called Placebo for people with fibromyalgia. The study is currently recruiting participants at 16 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAXS-14 (Esreboxetine)

AXS-14 tablets taken once daily

DRUGPlacebo

Placebo tablets taken once daily


Locations(16)

Clinical Research Site

Little Rock, Arkansas, United States

Clinical Research Site

Santa Ana, California, United States

Clinical Research Site

Cromwell, Connecticut, United States

Clinical Research Site

Jacksonville, Florida, United States

Clinical Research Site

Orlando, Florida, United States

Clinical Research Site

Tampa, Florida, United States

Clinical Research Site

Atlanta, Georgia, United States

Clinical Research Site

Overland Park, Kansas, United States

Clinical Research Site

Louisville, Kentucky, United States

Clinical Research Site

Prairieville, Louisiana, United States

Clinical Research Site

Springfield, Missouri, United States

Clinical Research Site

Town and Country, Missouri, United States

Clinical Research Site

Tulsa, Oklahoma, United States

Clinical Research Site

Charleston, South Carolina, United States

Clinical Research Site

Memphis, Tennessee, United States

Clinical Research Site

Prosper, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07398417


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