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NCT02277704 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Study of TNX-102 SL in Subjects With Military-Related PTSD and Related Conditions
A Phase 2 study, sponsored by Tonix Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 245
- Enrollment target
NCT02277704: Completed Phase 2 study, sponsored by Tonix Pharmaceuticals.
NCT02277704 is a Phase 2 study that has completed, run by Tonix Pharmaceuticals. The registered enrollment target is 245 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02277704, a Phase 2 study, has completed, sponsored by Tonix Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 245 participants
- Enrollment target
Study Summary
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.
Primary Outcome
The mean change from baseline (Visit 2) in the Total CAPS-5 score after 12 weeks of treatment evaluated at Visit 9 (Week 12). The primary efficacy comparison will be the change from baseline in total CAPS-5 score for the 2.8 mg treatment arm compared to placebo. CAPS-5 score ranges from 0-80 with lower scores indicating less severe PTSD symptoms.
Interventions
- DRUG Placebo
- DRUG TNX-102 SL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 245 participants |
| Start Date | 2014-10 |
| Est. Completion | 2016-05 |
| Phase | Phase 2 |
What the finished NCT02277704 record still lists
NCT02277704 is an interventional study that assigns participants to a tested intervention. The registered 245 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02277704 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02277704 about?
NCT02277704 is a clinical study titled "Safety and Efficacy Study of TNX-102 SL in Subjects With Military-Related PTSD and Related Conditions". 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 wi...
What is the current status of trial NCT02277704?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 245 participants. The study started on 2014-10. Estimated completion is 2016-05.
What interventions are being tested in trial NCT02277704?
The interventions under investigation include: Placebo (DRUG), TNX-102 SL (DRUG).
Who is sponsoring clinical trial NCT02277704?
This trial is sponsored by Tonix Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02277704's enrollment target sits among peer trials
245 234th of 2000 higher than 1,766 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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