A 3-Month Open-Label Safety and Efficacy Study of TNX-102 SL Tablets in Fibromyalgia Patients
Public ClinicalTrials.gov record NCT02589275. 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 3-Month, Multicenter, Open-Label Extension to Evaluate Safety and Efficacy of TNX-102 SL Tablets Taken Daily at Bedtime in Patients With Fibromyalgia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase 3, open-label, extension trial designed to evaluate the long term safety and efficacy over 3 months of TNX-102 SL tablets taken daily at bedtime for the treatment of Fibromyalgia (FM). Patients recruits into this trial are those who have successfully completed the double-blind studies; TNX-CY-F301 and TNX-CY-F302. Patients will not be made aware of the therapy they received during the double-blind study.
Study identification
- NCT ID
- NCT02589275
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 375 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- 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
- Aug 4, 2015 (Actual)
- Primary completion
- Sep 28, 2016 (Actual)
- Completion
- Sep 28, 2016 (Actual)
- Last update posted
- Feb 20, 2025
2015 – 2016
United States locations
- U.S. sites
- 33
- U.S. states
- 20
- U.S. cities
- 33
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | 35216 | — |
| Not listed | Phoenix | Arizona | 85032 | — |
| Not listed | Sacramento | California | 95825 | — |
| Not listed | San Diego | California | 92103 | — |
| Not listed | Brandon | Florida | 33511 | — |
| Not listed | DeLand | Florida | 32720 | — |
| Not listed | Lakeland | Florida | 33805 | — |
| Not listed | Ocala | Florida | 34471 | — |
| Not listed | Orlando | Florida | 32806 | — |
| Not listed | Tampa | Florida | 33614 | — |
| Not listed | West Palm Beach | Florida | 33409 | — |
| Not listed | Columbus | Georgia | 31904 | — |
| Not listed | Smyrna | Georgia | 30080 | — |
| Not listed | Evansville | Indiana | 47714 | — |
| Not listed | North Dartmouth | Massachusetts | 02747 | — |
| Not listed | Ann Arbor | Michigan | 48104 | — |
| Not listed | Jackson | Mississippi | 39202 | — |
| Not listed | Williamsville | New York | 14221 | — |
| Not listed | Cincinnati | Ohio | 45206 | — |
| Not listed | Middleburg Heights | Ohio | 44130 | — |
| Not listed | Medford | Oregon | 97504 | — |
| Not listed | Portland | Oregon | 97210 | — |
| Not listed | Allentown | Pennsylvania | 18104 | — |
| Not listed | Warwick | Rhode Island | 02888 | — |
| Not listed | Greer | South Carolina | 29650 | — |
| Not listed | Mt. Pleasant | South Carolina | 29464 | — |
| Not listed | Dallas | Texas | 75231 | — |
| Not listed | Salt Lake City | Utah | 84102 | — |
| Not listed | Charlottesville | Virginia | 22911 | — |
| Not listed | Norfolk | Virginia | 23507 | — |
| Not listed | Bellevue | Washington | 98007 | — |
| Not listed | Seattle | Washington | 98104 | — |
| Not listed | Kenosha | Wisconsin | 53142 | — |
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 NCT02589275, 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 20, 2025 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02589275 live on ClinicalTrials.gov.