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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 is a Phase 3 study that was terminated before completion, run by Tonix Pharmaceuticals. The registered enrollment target is 192 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03841773
The ClinicalTrials.gov registry entry for NCT03841773 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 192 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.
NCT03841773 reports 0 study locations.
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.
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