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ENROLLING BY INVITATION
NCT07637162
PHASE3

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

Sponsor: Axsome Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2026-04-29

Completion Date

2028-05

Last Updated

2026-09-04

Healthy Volunteers

No

Conditions

Interventions

DRUG

AXS-14 (esreboxetine)

AXS-14 tablets taken twice daily.

Locations (31)

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Little Rock, Arkansas, United States

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Redlands, California, United States

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Sacramento, California, United States

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Santa Ana, California, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Lakeland, Florida, United States

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Orlando, Florida, United States

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Orlando, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Norcross, Georgia, United States

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Chicago, Illinois, United States

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Overland Park, Kansas, United States

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Overland Park, Kansas, United States

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Louisville, Kentucky, United States

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Prairieville, Louisiana, United States

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Boston, Massachusetts, United States

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Springfield, Missouri, United States

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Town and Country, Missouri, United States

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Las Vegas, Nevada, United States

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Brooklyn, New York, United States

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Williamsville, New York, United States

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Tulsa, Oklahoma, United States

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Duncansville, Pennsylvania, United States

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Charleston, South Carolina, United States

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Knoxville, Tennessee, United States

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Memphis, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Prosper, Texas, United States