Safety and Efficacy Study of TNX-102 SL in Patients With Military-related PTSD
Public ClinicalTrials.gov record NCT03062540. 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 Taken Daily at Bedtime in Patients With Military-Related PTSD
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study that will investigate the efficacy and safety of 5.6 mg TNX-102 SL (2 x 2.8 mg tablets)-a sublingual formulation of cyclobenzaprine. Following successful screening and randomization, eligible patients will have a telephonic visit at week 2 and then return regularly to the study clinic for monthly visits for assessments of efficacy and safety.
Study identification
- NCT ID
- NCT03062540
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 358 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
- Mar 27, 2017 (Actual)
- Primary completion
- Jul 27, 2018 (Actual)
- Completion
- Jul 27, 2018 (Actual)
- Last update posted
- May 22, 2024
2017 – 2018
United States locations
- U.S. sites
- 44
- U.S. states
- 23
- U.S. cities
- 43
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Phoenix | Phoenix | Arizona | 85032 | — |
| Little Rock | Little Rock | Arkansas | 72211 | — |
| Rogers | Rogers | Arkansas | 72758 | — |
| Beverly hills | Beverly Hills | California | 90210 | — |
| Glendale | Glendale | California | 91206 | — |
| Oakland | Oakland | California | 94607 | — |
| Oceanside | Oceanside | California | 92056 | — |
| Orange | Orange | California | 92868 | — |
| Riverside | Riverside | California | 92506 | — |
| San Diego | San Diego | California | 92123 | — |
| San Diego | San Diego | California | 92161 | — |
| Temecula | Temecula | California | 92591 | — |
| Colorado Springs | Colorado Springs | Colorado | 80910 | — |
| Cromwell | Cromwell | Connecticut | 06416 | — |
| Norwich | Norwich | Connecticut | 06360 | — |
| Washington, D.C. | Washington D.C. | District of Columbia | 20018 | — |
| Jacksonville | Jacksonville | Florida | 32256 | — |
| Lake City | Lake City | Florida | 32607 | — |
| Lauderhill | Lauderhill | Florida | 33319 | — |
| Maitland | Maitland | Florida | 32751 | — |
| Tampa | Tampa | Florida | 33609 | — |
| Atlanta | Atlanta | Georgia | 30341 | — |
| Chicago | Chicago | Illinois | 60640 | — |
| New Bedford | New Bedford | Massachusetts | 02740 | — |
| Flowood | Flowood | Mississippi | 39232 | — |
| St. Louis | St Louis | Missouri | 63141 | — |
| Missoula | Missoula | Montana | 59812 | — |
| Las Vegas | Las Vegas | Nevada | 89102 | — |
| Berlin | Berlin | New Jersey | 08009 | — |
| Cedarhurst | Cedarhurst | New York | 11516 | — |
| New York | New York | New York | 10128 | — |
| Canton | Canton | Ohio | 44718 | — |
| Cincinnati | Cincinnati | Ohio | 45219 | — |
| Dayton | Dayton | Ohio | 45417 | — |
| Oklahoma City | Oklahoma City | Oklahoma | 73103 | — |
| Downingtown | Downingtown | Pennsylvania | 19335 | — |
| Media | Media | Pennsylvania | 19063 | — |
| Charleston | Charleston | South Carolina | 29407 | — |
| Austin | Austin | Texas | 78754 | — |
| Dallas | Dallas | Texas | 75231 | — |
| Houston | Houston | Texas | 77098 | — |
| San Antonio | San Antonio | Texas | 78229 | — |
| Salem | Salem | Virginia | 24153 | — |
| Everett | Everett | Washington | 98201 | — |
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 NCT03062540, 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 May 22, 2024 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03062540 live on ClinicalTrials.gov.