Repeat of: A Study to Evaluate Efficacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With Fibromyalgia
Public ClinicalTrials.gov record NCT02829814. 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 Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study To Evaluate The EFFIcacy and 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.
The present trial is designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets, taken daily at bedtime after 12 weeks of treatment in patients with fibromyalgia. The use of low-dose sublingual formulation of cyclobenzaprine (TNX-102 SL) dosed nightly for fibromyalgia is supported by the results of TNX-CY-F202 Phase 2b study -- the results provide strong evidence that TNX-102 SL 2.8 mg dosed nightly results in beneficial effects upon pain, sleep and other FM symptomatology.
Study identification
- NCT ID
- NCT02829814
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 51 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
- Jul 22, 2016 (Actual)
- Primary completion
- Sep 13, 2016 (Actual)
- Completion
- Sep 13, 2016 (Actual)
- Last update posted
- Feb 25, 2025
2016
United States locations
- U.S. sites
- 32
- U.S. states
- 20
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | 35216 | — |
| Not listed | Phoenix | Arizona | 85032 | — |
| Not listed | Oceanside | California | 92056 | — |
| Not listed | San Diego | California | 92103 | — |
| Not listed | Brandon | Florida | 33511 | — |
| Not listed | DeLand | Florida | 32720 | — |
| Not listed | Ocala | Florida | 34471 | — |
| Not listed | Orlando | Florida | 32801 | — |
| Not listed | Tampa | Florida | 33613 | — |
| Not listed | Tampa | Florida | 33614 | — |
| Not listed | West Palm Beach | Florida | 33409 | — |
| Not listed | Evansville | Indiana | 47714 | — |
| Not listed | Indianapolis | Indiana | 46260 | — |
| Not listed | Jackson | Mississippi | 39202 | — |
| Not listed | Las Vegas | Nevada | 89102 | — |
| Not listed | Cedarhurst | New York | 11516 | — |
| Not listed | Williamsville | New York | 14221 | — |
| Not listed | Raleigh | North Carolina | 27612 | — |
| Not listed | Fargo | North Dakota | 58103 | — |
| Not listed | Canton | Ohio | 44718 | — |
| Not listed | Cincinnati | Ohio | 45219 | — |
| Not listed | Medford | Oregon | 97504 | — |
| Not listed | Portland | Oregon | 97210 | — |
| Not listed | Salem | Oregon | 97301 | — |
| Not listed | Allentown | Pennsylvania | 18104 | — |
| Not listed | Warwick | Rhode Island | 02888 | — |
| Not listed | Mt. Pleasant | South Carolina | 29464 | — |
| Not listed | Chattanooga | Tennessee | 37421 | — |
| Not listed | Dallas | Texas | 75231 | — |
| Not listed | Salt Lake City | Utah | 84102 | — |
| 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 NCT02829814, 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 25, 2025 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02829814 live on ClinicalTrials.gov.