A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD
Public ClinicalTrials.gov record NCT03841773. 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 in Participants With PTSD Taken Daily at Bedtime (Protocol No. TNX-CY-P302)
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 TNX-102 SL 5.6 mg (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
- NCT03841773
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 192 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 7, 2019 (Actual)
- Primary completion
- Apr 24, 2020 (Actual)
- Completion
- Apr 24, 2020 (Actual)
- Last update posted
- Feb 6, 2025
2019 – 2020
United States locations
- U.S. sites
- 30
- U.S. states
- 17
- U.S. cities
- 30
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ashild Peters | Phoenix | Arizona | 85012 | — |
| Ashild Peters | Little Rock | Arkansas | 72211 | — |
| Ashild Peters | Rogers | Arkansas | 72758 | — |
| Ashild Peters | Beverly Hills | California | 90210 | — |
| Ashild Peters | Oceanside | California | 92056 | — |
| Ashild Peters | Orange | California | 92868 | — |
| Ashild Peters | Panorama City | California | 91402 | — |
| Ashild Peters | Riverside | California | 92506 | — |
| Ashild Peters | San Diego | California | 92123 | — |
| Ashild Peters | Temecula | California | 92591 | — |
| Ashild Peters | Colorado Springs | Colorado | 80910 | — |
| Ashild Peters | Norwich | Connecticut | 06360 | — |
| Ashild Peters | Washington D.C. | District of Columbia | 20011 | — |
| Ashild Peters | Jacksonville | Florida | 32256 | — |
| Ashild Peters | North Miami | Florida | 33161 | — |
| Ashild Peters | Orlando | Florida | 32801 | — |
| Ashild Peters | Tampa | Florida | 33614 | — |
| Ashild Peters | Alpharetta | Georgia | 30341 | — |
| Ashild Peters | Lincolnwood | Illinois | 60712 | — |
| Ashild Peters | Boston | Massachusetts | 02131 | — |
| Ashild Peters | New Bedford | Massachusetts | 02740 | — |
| Ashild Peters | Flowood | Mississippi | 39232 | — |
| Ashild Peters | St Louis | Missouri | 63141 | — |
| Ashild Peters | Las Vegas | Nevada | 89102 | — |
| Ashild Peters | Oklahoma City | Oklahoma | 73106 | — |
| Ashild Peters | Portland | Oregon | 97214 | — |
| Ashild Peters | Salem | Oregon | 97301 | — |
| Ashild Peters | Memphis | Tennessee | 38119 | — |
| Ashild Peters | Austin | Texas | 78737 | — |
| Ashild Peters | Dallas | Texas | 75231 | — |
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 NCT03841773, 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 6, 2025 · 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 NCT03841773 live on ClinicalTrials.gov.