Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design
Public ClinicalTrials.gov record NCT07398417. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Assess the Efficacy and Safety of AXS-14 in the Management of Fibromyalgia
Study identification
- NCT ID
- NCT07398417
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Axsome Therapeutics, Inc.
- Industry
- Enrollment
- 620 participants
Conditions and interventions
Conditions
Interventions
- AXS-14 (Esreboxetine) Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 13, 2026
- Primary completion
- Feb 29, 2028
- Completion
- Feb 29, 2028
- Last update posted
- Feb 8, 2026
2026 – 2028
United States locations
- U.S. sites
- 16
- U.S. states
- 13
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Research Site | Little Rock | Arkansas | 72211 | Recruiting |
| Clinical Research Site | Santa Ana | California | 92705 | Recruiting |
| Clinical Research Site | Cromwell | Connecticut | 06416 | Recruiting |
| Clinical Research Site | Jacksonville | Florida | 32256 | Recruiting |
| Clinical Research Site | Orlando | Florida | 32801 | Recruiting |
| Clinical Research Site | Tampa | Florida | 33634 | Recruiting |
| Clinical Research Site | Atlanta | Georgia | 30329 | Recruiting |
| Clinical Research Site | Overland Park | Kansas | 66209 | Recruiting |
| Clinical Research Site | Louisville | Kentucky | 40205 | Recruiting |
| Clinical Research Site | Prairieville | Louisiana | 70769 | Recruiting |
| Clinical Research Site | Springfield | Missouri | 65807 | Recruiting |
| Clinical Research Site | Town and Country | Missouri | 63017 | Recruiting |
| Clinical Research Site | Tulsa | Oklahoma | 74133 | Recruiting |
| Clinical Research Site | Charleston | South Carolina | 29407 | Recruiting |
| Clinical Research Site | Memphis | Tennessee | 38119 | Recruiting |
| Clinical Research Site | Prosper | Texas | 75078 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07398417, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 8, 2026 · Synced May 20, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07398417 live on ClinicalTrials.gov.