Safety and Efficacy Study of TNX-102 SL in Subjects With Military-Related PTSD and Related Conditions
Public ClinicalTrials.gov record NCT02277704. 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 2, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken at Bedtime in Subjects With Military-Related PTSD and Related Conditions (Protocol No. TNX-CY-P201) -"AtEase STUDY"
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, parallel-group study that will investigate the efficacy and safety of two doses of TNX-102 SL -a sublingual formulation of cyclobenzaprine. Following successful screening and randomization, eligible subjects will return regularly to the study clinic for weekly or biweekly visits for assessments of efficacy and safety.
Study identification
- NCT ID
- NCT02277704
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 245 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
- Oct 2014 (Actual)
- Primary completion
- May 2016 (Actual)
- Completion
- May 2016 (Actual)
- Last update posted
- Jun 20, 2024
2014 – 2016
United States locations
- U.S. sites
- 23
- U.S. states
- 14
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Tuscaloosa VA Medical Center | Tuscaloosa | Alabama | 35404 | — |
| Noesis Pharma | Phoenix | Arizona | 85032 | — |
| Sun Valley Research Center | Imperial | California | 92251 | — |
| National City | National City | California | 91950 | — |
| Excell Research, Inc | Oceanside | California | 92506 | — |
| Neuropsychiatric Research Center of Orange County | Orange | California | 92868 | — |
| CITRIALS | Riverside | California | 92506 | — |
| Veteran Affairs, San Diego Health Care System | San Diego | California | 92161 | — |
| Cns, Inc. | Torrance | California | 90502 | — |
| Sarkis Clinical Trials | Lake City | Florida | 32025 | — |
| Compass Research North, LLC | Leesburg | Florida | 34748 | — |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32801 | — |
| Atlanta Center For Medical Research | Atlanta | Georgia | 30308 | — |
| Great Lakes Clinical Trials | Chicago | Illinois | 60640 | — |
| Novex Clinical Research | New Bedford | Massachusetts | 02740 | — |
| Premier Psychiatric Research Institute, Inc. | Lincoln | Nebraska | 68526 | — |
| Altea Research | Las Vegas | Nevada | 89102 | — |
| Cedarhurst | Cedarhurst | New York | 11516 | — |
| Cincinnati | Cincinnati | Ohio | 45219 | — |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | — |
| IPS Research Company | Oklahoma City | Oklahoma | 73103 | — |
| Clinical Trials of Texas | San Antonio | Texas | 78229 | — |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | — |
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 NCT02277704, 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 Jun 20, 2024 · Synced Oct 18, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02277704 live on ClinicalTrials.gov.