Recruiting

Phase 3

AXS-14Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design

Sponsor:

Axsome Therapeutics, Inc.

Code:

NCT07398417

Conditions

Fibromyalgia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AXS-14 (Esreboxetine)

Placebo

Study Details

Brief 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.

Conditions

Fibromyalgia

Study ID

NCT07398417

Start date

Jan 14, 2026

Status verified date

Sep, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

620 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: AXS-14 (esreboxetine)

Up to 12 weeks in the open-label period;
Up to 12 weeks in the randomized double-blind period (if applicable)

placebo comparator: Placebo

• Up to 12 weeks in the randomized double-blind period (if applicable)

Interventions

AXS-14 (Esreboxetine)

AXS-14 tablets taken once daily

Placebo

Placebo tablets taken once daily

Primary outcome measure

Time from randomization to loss of therapeutic response [ Time Frame: 12 Weeks ]

Central Contacts and Locations

Central contacts

Study Director

212-332-5061 AXS-14-FM-301@axsome.com

Locations

Clinical Research Site

Recruiting

Glendale, Arizona, United States, 85308

Clinical Research Site

Recruiting

Phoenix, Arizona, United States, 85032

Clinical Research Site

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Tucson, Arizona, United States, 85704

Clinical Research Site

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Little Rock, Arkansas, United States, 72211

Clinical Research Site

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Anaheim, California, United States, 92801

Clinical Research Site

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Oceanside, California, United States, 92056

Clinical Research Site

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Redlands, California, United States, 92374

Clinical Research Site

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Sacramento, California, United States, 95821

Clinical Research Site

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Santa Ana, California, United States, 92705

Clinical Research Site

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Cromwell, Connecticut, United States, 06416

Clinical Research Site

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Hollywood, Florida, United States, 33021

Clinical Research Site

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Jacksonville, Florida, United States, 32256

Clinical Research Site

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Lakeland, Florida, United States, 33803

Clinical Research Site

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Maitland, Florida, United States, 32751

Clinical Research Site

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Orlando, Florida, United States, 32801

Clinical Research Site

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Orlando, Florida, United States, 32832

Clinical Research Site

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Tampa, Florida, United States, 33634

Clinical Research Site

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The Villages, Florida, United States, 32159

Clinical Research Site

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Atlanta, Georgia, United States, 30328

Clinical Research Site

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Atlanta, Georgia, United States, 30329

Clinical Research Site

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Marietta, Georgia, United States, 30060

Clinical Research Site

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Norcross, Georgia, United States, 30092

Clinical Research Site

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Chicago, Illinois, United States, 60634

Clinical Research Site

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Tinley Park, Illinois, United States, 60477

Clinical Research Site

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Kansas City, Kansas, United States, 66160

Clinical Research Site

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Overland Park, Kansas, United States, 66209

Clinical Research Site

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Overland Park, Kansas, United States, 66212

Clinical Research Site

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Louisville, Kentucky, United States, 40205

Clinical Research Site

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Prairieville, Louisiana, United States, 70769

Clinical Research Site

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Boston, Massachusetts, United States, 02131

Clinical Research Site

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Watertown, Massachusetts, United States, 02472

Clinical Research Site

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Hazelwood, Missouri, United States, 63042

Clinical Research Site

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Springfield, Missouri, United States, 65807

Clinical Research Site

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Town and Country, Missouri, United States, 63017

Clinical Research Site

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Las Vegas, Nevada, United States, 89102

Clinical Research Site

Recruiting

Brooklyn, New York, United States, 11235

Clinical Research Site

Recruiting

Hartsdale, New York, United States, 10530

Clinical Research Site

Recruiting

Williamsville, New York, United States, 14221

Houston

Recruiting

High Point, North Carolina, United States, 27260

Clinical Research Site

Recruiting

Huber Heights, Ohio, United States, 45424

Clinical Research Site

Recruiting

Milford, Ohio, United States, 45150

Clinical Research Site

Recruiting

Tulsa, Oklahoma, United States, 74133

Clinical Research Site

Recruiting

Duncansville, Pennsylvania, United States, 16635

Clinical Research Site

Recruiting

Cranston, Rhode Island, United States, 02920

Clinical Research Site

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Knoxville, Tennessee, United States, 37909

Clinical Research Site

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Memphis, Tennessee, United States, 38119

Clinical Research Site

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Austin, Texas, United States, 78731

Clinical Research Site

Recruiting

Austin, Texas, United States, 78737

Clinical Research Site

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Dallas, Texas, United States, 75251

Clinical Research Site

Recruiting

Houston, Texas, United States, 77089

Clinical Research Site

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Prosper, Texas, United States, 75078

Clinical Research Site

Recruiting

San Antonio, Texas, United States, 78240

Clinical Research Site

Recruiting

The Woodlands, Texas, United States, 77832

More Information

Sponsor

Axsome Therapeutics, Inc.

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

Fibromyalgia
Central Sensitization
Allodynia
Hyperalgesia
Hypersensitivity to sensory stimuli
Inhibitor of the norepinephrine transporter (NET)
Esreboxetine
AXS-14
Axsome
Norepinephrine reuptake inhibitor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Axsome Therapeutics, Inc. on 2026-09-04.