A Study to Evaluate eFFIcacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With fibRoMyalgia
Public ClinicalTrials.gov record NCT02436096. 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 use of low-dose CBP dosed nightly at bedtime for FM was supported by the results of Tonix' TNX-CY-F202 Phase 2b study (also referred to as the BESTFIT Study). The TNX-CY-F202 study provided evidence that TNX-102 SL 2.8 mg dosed nightly results in beneficial effects upon pain, sleep and other FM symptomatology. The present trial is designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets, taken daily at bedtime over 12 weeks to treat fibromyalgia.
Study identification
- NCT ID
- NCT02436096
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 519 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
- Apr 2015 (Type not available)
- Primary completion
- Sep 2016 (Actual)
- Completion
- Sep 2016 (Actual)
- Last update posted
- Feb 7, 2025
2015 – 2016
United States locations
- U.S. sites
- 35
- U.S. states
- 20
- U.S. cities
- 34
| 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 | 33613 | — |
| 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 | Columbus | Ohio | 43212 | — |
| 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 NCT02436096, 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 7, 2025 · Synced Oct 29, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02436096 live on ClinicalTrials.gov.