Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact
Clinical Trials in the USA / NCT07637162
Enrolling by invitation Phase 3

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

NCT07637162 · tracked via the Priya Life Science USA tracker
Sponsor
Axsome Therapeutics, Inc
Phase
Phase 3
Started
2026-04-29
Last updated
2026-10-13

Condition(s) studied

Fibromyalgia

Investigational drug(s) / intervention(s)

AXS-14 (esreboxetine) →

AXS-14 (esreboxetine): AXS-14 tablets taken twice daily.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Participation in AXS-14-FM-301. Exclusion Criteria: * Unable to comply with study procedures. * Medically inappropriate for study participation in the opinion of the Investigator.

Primary outcome measure(s)

  • Long-term Safety — Up to 52 weeks.
    Incidence of treatment-emergent adverse events following dosing with AXS-14

Trial sites (35)

FacilityCityRegionStatus
Clinical Research Site Little Rock Arkansas
Clinical Research Site Oceanside California
Clinical Research Site Redlands California
Clinical Research Site Sacramento California
Clinical Research Site Santa Ana California
Clinical Research Site Cromwell Connecticut
Clinical Research Site Hollywood Florida
Clinical Research Site Jacksonville Florida
Clinical Research Site Lakeland Florida
Clinical Research Site Orlando Florida
Clinical Research Site Orlando Florida
Clinical Research Site Tampa Florida
Clinical Research Site The Villages Florida
Clinical Research Site Atlanta Georgia
Clinical Research Site Norcross Georgia
Clinical Research Site Chicago Illinois
Clinical Research Site Overland Park Kansas
Clinical Research Site Overland Park Kansas
Clinical Research Site Louisville Kentucky
Clinical Research Site Prairieville Louisiana
Clinical Research Site Boston Massachusetts
Clinical Research Site Watertown Massachusetts
Clinical Research Site Springfield Missouri
Clinical Research Site Town and Country Missouri
Clinical Research Site Las Vegas Nevada
Clinical Research Site Brooklyn New York
Clinical Research Site Williamsville New York
Clinical Research Site Tulsa Oklahoma
Clinical Research Site Duncansville Pennsylvania
Clinical Research Site Charleston South Carolina
Clinical Research Site Knoxville Tennessee
Clinical Research Site Memphis Tennessee
Clinical Research Site Austin Texas
Clinical Research Site Dallas Texas
Clinical Research Site Prosper Texas

More Axsome Therapeutics, Inc. trials in the USA

An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD Enrolling by invitation
Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol Recruiting
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2) Recruiting
Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design Recruiting
A Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Subjects With Binge Eating Disorder Enrolling by invitation

Other trials for the same condition

Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design Recruiting
Ultrasonic Neuromodulation of Cingulate Cortex for Fibromyalgia Recruiting
The Effect of Remote Electrical Neuromodulation (REN) on Conditioned Pain Modulation (CPM) in Migraine and Fibromyalgia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07637162 on ClinicalTrials.gov ↗ ← All trials in the USA