12-Month Open-Label Long-term Safety Study of TNX-102 SL Tablets in Fibromyalgia Patients
Public ClinicalTrials.gov record NCT02015234. 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 12-Month, Multicenter, Open-Label Extension Study (F202) to Evaluate the Long-term Safety 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 was an open-label, extension trial designed to evaluate the long-term safety over 12 months of TNX-102 SL tablets taken daily at bedtime for the treatment of fibromyalgia. Patients recruited into this trial were those who had successfully completed the double-blind study, TNX-CY-F202 (F202) (NCT01903265). Patients were not made aware of the therapy they received during the double-blind study.
Study identification
- NCT ID
- NCT02015234
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 158 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 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
- Dec 2013 (Type not available)
- Primary completion
- Aug 2015 (Actual)
- Completion
- Aug 2015 (Actual)
- Last update posted
- Jul 7, 2017
2013 – 2015
United States locations
- U.S. sites
- 13
- U.S. states
- 9
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Denver | Denver | Colorado | 80239 | — |
| 16176 Cortez Boulevard | Brooksville | Florida | 34601 | — |
| 100 West Gore Street | Orlando | Florida | 32806 | — |
| 71 Thomas Johnson Drive | Frederick | Maryland | 21702 | — |
| 370 Faunce Corner Road | North Dartmouth | Massachusetts | 02747 | — |
| Worcester | Worcester | Massachusetts | 01605 | — |
| Jackson | Jackson | Mississippi | 39202 | — |
| Cincinnati | Cincinnati | Ohio | 45219 | — |
| 1275 Olentangy River Road | Columbus | Ohio | 43212 | — |
| 18660 Bagley Road | Middleburg Heights | Ohio | 44130 | — |
| 1001 South Market Street | Mechanicsburg | Pennsylvania | 17055 | — |
| 322 Memorial Drive | Greer | South Carolina | 29650 | — |
| 601 Broadway | Seattle | Washington | 98122 | — |
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 NCT02015234, 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 Jul 7, 2017 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02015234 live on ClinicalTrials.gov.