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

Fibromyalgia

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(51)

Clinical Research Site

Glendale, Arizona, United States

Clinical Research Site

Phoenix, Arizona, United States

Clinical Research Site

Tucson, Arizona, United States

Clinical Research Site

Little Rock, Arkansas, United States

Clinical Research Site

Anaheim, California, United States

Clinical Research Site

Oceanside, California, United States

Clinical Research Site

Redlands, California, United States

Clinical Research Site

Sacramento, California, United States

Clinical Research Site

Santa Ana, California, United States

Clinical Research Site

Cromwell, Connecticut, United States

Clinical Research Site

Hollywood, Florida, United States

Clinical Research Site

Jacksonville, Florida, United States

Clinical Research Site

Lakeland, Florida, United States

Clinical Research Site

Maitland, Florida, United States

Clinical Research Site

Orlando, Florida, United States

Clinical Research Site

Orlando, Florida, United States

Clinical Research Site

Tampa, Florida, United States

Clinical Research Site

The Villages, Florida, United States

Clinical Research Site

Atlanta, Georgia, United States

Clinical Research Site

Atlanta, Georgia, United States

Clinical Research Site

Marietta, Georgia, United States

Clinical Research Site

Norcross, Georgia, United States

Clinical Research Site

Chicago, Illinois, United States

Clinical Research Site

Tinley Park, Illinois, United States

Clinical Research Site

Overland Park, Kansas, 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

Boston, Massachusetts, United States

Clinical Research Site

Watertown, Massachusetts, United States

Clinical Research Site

Hazelwood, Missouri, United States

Clinical Research Site

Springfield, Missouri, United States

Clinical Research Site

Town and Country, Missouri, United States

Clinical Research Site

Las Vegas, Nevada, United States

Clinical Research Site

Brooklyn, New York, United States

Clinical Research Site

Hartsdale, New York, United States

Clinical Research Site

Williamsville, New York, United States

Houston

High Point, North Carolina, United States

Clinical Research Site

Huber Heights, Ohio, United States

Clinical Research Site

Milford, Ohio, United States

Clinical Research Site

Tulsa, Oklahoma, United States

Clinical Research Site

Duncansville, Pennsylvania, United States

Clinical Research Site

Cranston, Rhode Island, United States

Clinical Research Site

Knoxville, Tennessee, United States

Clinical Research Site

Memphis, Tennessee, United States

Clinical Research Site

Austin, Texas, United States

Clinical Research Site

Austin, Texas, United States

Clinical Research Site

Dallas, Texas, United States

Clinical Research Site

Houston, Texas, United States

Clinical Research Site

Prosper, Texas, United States

Clinical Research Site

San Antonio, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07398417

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