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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 is a Phase 3 study that was terminated before completion, run by Tonix Pharmaceuticals. The registered enrollment target is 358 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03062540
The ClinicalTrials.gov registry entry for NCT03062540 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 358 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tonix Pharmaceuticals, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which TNX-102 SL is the first listed.
NCT03062540 reports 0 study locations.
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.
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