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NCT03062540 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of TNX-102 SL in Patients With Military-related PTSD
A Phase 3 study, sponsored by Tonix Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 358
- Enrollment target
NCT03062540: Clinical Trial Phase 3 study, sponsored by Tonix Pharmaceuticals.
NCT03062540 is a Phase 3 study that was terminated before completion, run by Tonix Pharmaceuticals. The registered enrollment target is 358 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03062540, a Phase 3 study, was terminated before completion, sponsored by Tonix Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 358 participants
- Enrollment target
Study Summary
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.
Primary Outcome
To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the Clinician Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (CAPS-5) total symptom severity score in a 12-week study. Score ranges from 0 to 80 with lower scores indicating less severe PTSD symptoms.
Interventions
- DRUG TNX-102 SL
- DRUG Placebo SL Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 358 participants |
| Start Date | 2017-03-27 |
| Est. Completion | 2018-07-27 |
| Phase | Phase 3 |
Why NCT03062540 stopped before completion
NCT03062540 is an interventional study that assigns participants to a tested intervention. The registered 358 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (54% lower).
The record links to 0 conditions, and to 2 interventions - of which TNX-102 SL is the first listed.
NCT03062540 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03062540 about?
NCT03062540 is a clinical study titled "Safety and Efficacy Study of TNX-102 SL in Patients With Military-related PTSD". 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...
What is the current status of trial NCT03062540?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 358 participants. The study started on 2017-03-27. Estimated completion is 2018-07-27.
What interventions are being tested in trial NCT03062540?
The interventions under investigation include: TNX-102 SL (DRUG), Placebo SL Tablet (DRUG).
Who is sponsoring clinical trial NCT03062540?
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 NCT03062540's enrollment target sits among peer trials
358 1022nd of 2000 higher than 978 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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