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NCT03841773 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD
A Phase 3 study, sponsored by Tonix Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 192
- Enrollment target
NCT03841773: Clinical Trial Phase 3 study, sponsored by Tonix Pharmaceuticals.
NCT03841773 is a Phase 3 study that was terminated before completion, run by Tonix Pharmaceuticals. The registered enrollment target is 192 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03841773, a Phase 3 study, was terminated before completion, sponsored by Tonix Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 192 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 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.
Primary Outcome
The primary efficacy endpoint is the mean change from baseline (Day 1) in the total CAPS-5 score after 12 weeks of treatment. The CAPS-5 is an updated and validated version of a semi-structured interview that has been designed to assess the essential features of PTSD as defined by the DSM-5. The total score ranges from 0 to 80 with higher scores indicating more severe PTSD symptoms.
Interventions
- DRUG TNX-102 SL
- DRUG Placebo SL Tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 192 participants |
| Start Date | 2019-03-07 |
| Est. Completion | 2020-04-24 |
| Phase | Phase 3 |
Why NCT03841773 stopped before completion
NCT03841773 is an interventional study that assigns participants to a tested intervention. The registered 192 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 (75% lower).
The record links to 0 conditions, and to 2 interventions - of which TNX-102 SL is the first listed.
NCT03841773 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03841773 about?
NCT03841773 is a clinical study titled "A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD". 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 wi...
What is the current status of trial NCT03841773?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 192 participants. The study started on 2019-03-07. Estimated completion is 2020-04-24.
What interventions are being tested in trial NCT03841773?
The interventions under investigation include: TNX-102 SL (DRUG), Placebo SL Tablets (DRUG).
Who is sponsoring clinical trial NCT03841773?
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 NCT03841773's enrollment target sits among peer trials
192 1398th of 2000 higher than 599 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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