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NCT07398417 · ClinicalTrials.gov registry record · Phase 3
Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design
A Phase 3 study of Fibromyalgia, sponsored by Axsome Therapeutics.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 620
- Enrollment target
- 16
- Study locations
NCT07398417 is a Phase 3 study of Fibromyalgia that is actively recruiting participants, run by Axsome Therapeutics. The registered enrollment target is 620 participants, above the 171-participant average among 76 other Fibromyalgia trials with a reported enrollment target (263% higher). The trial reports 16 study locations across 13 states.
The verdict
NCT07398417, a Phase 3 study of Fibromyalgia, is actively recruiting participants, sponsored by Axsome Therapeutics.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 620 participants
- Enrollment target
- 16
- Study locations
Study 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 Studied
Interventions
- DRUG Placebo
- DRUG AXS-14 (Esreboxetine)
Study Locations (16)
Florida
- Clinical Research Site - Jacksonville
- Clinical Research Site - Orlando
- Clinical Research Site - Tampa
Missouri
- Clinical Research Site - Springfield
- Clinical Research Site - Town and Country
Arkansas
- Clinical Research Site - Little Rock
California
- Clinical Research Site - Santa Ana
Connecticut
- Clinical Research Site - Cromwell
Georgia
- Clinical Research Site - Atlanta
Kansas
- Clinical Research Site - Overland Park
Kentucky
- Clinical Research Site - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 620 participants |
| Start Date | 2026-01-14 |
| Est. Completion | 2028-03 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07398417
The ClinicalTrials.gov registry entry for NCT07398417 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 620 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 171-participant average among 76 other Fibromyalgia trials with a reported enrollment target (263% higher). The listed sponsor is Axsome Therapeutics, which has 28 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Fibromyalgia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT07398417 reports 16 study locations spanning 13 distinct geographic areas - top geographies include Florida, Missouri, Arkansas.
Frequently Asked Questions
What is clinical trial NCT07398417 about?
NCT07398417 is a clinical study titled "Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design". 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.
What is the current status of trial NCT07398417?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 620 participants. The study started on 2026-01-14. Estimated completion is 2028-03.
What conditions does trial NCT07398417 study?
This clinical trial studies the following conditions: Fibromyalgia.
What interventions are being tested in trial NCT07398417?
The interventions under investigation include: Placebo (DRUG), AXS-14 (Esreboxetine) (DRUG).
Who is sponsoring clinical trial NCT07398417?
This trial is sponsored by Axsome Therapeutics, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07398417 being conducted?
This trial has 16 study locations across Arkansas, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.