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NCT03110575 · ClinicalTrials.gov registry record · Phase 3
12-Week Open-Label Extension Study of TNX-102 SL in PTSD Patients
A Phase 3 study, sponsored by Tonix Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 190
- Enrollment target
NCT03110575: Clinical Trial Phase 3 study, sponsored by Tonix Pharmaceuticals.
NCT03110575 is a Phase 3 study that was terminated before completion, run by Tonix Pharmaceuticals. The registered enrollment target is 190 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
NCT03110575, a Phase 3 study, was terminated before completion, sponsored by Tonix Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 190 participants
- Enrollment target
Study Summary
This is an open-label, extension trial designed to evaluate safety over 12 additional weeks of TNX-102 SL therapy taken daily at bedtime for the treatment of PTSD. Patients recruited into this trial are those who have successfully completed the double-blind lead-in study.
Primary Outcome
Adverse events will be coded using the latest version of the Medical Dictionary for Regulatory Activities (MedDRA) and will be summarized overall and by preferred term and system organ class.
Interventions
- DRUG TNX-102 SL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 190 participants |
| Start Date | 2017-06-20 |
| Est. Completion | 2018-07-27 |
| Phase | Phase 3 |
Why NCT03110575 stopped before completion
NCT03110575 is an interventional study that assigns participants to a tested intervention. The registered 190 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 1 intervention - of which TNX-102 SL is the first listed.
NCT03110575 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03110575 about?
NCT03110575 is a clinical study titled "12-Week Open-Label Extension Study of TNX-102 SL in PTSD Patients". This is an open-label, extension trial designed to evaluate safety over 12 additional weeks of TNX-102 SL therapy taken daily at bedtime for the treatment of PTSD. Patients recruited into this trial are those who have successfully completed the double-blind lead-in study.
What is the current status of trial NCT03110575?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 190 participants. The study started on 2017-06-20. Estimated completion is 2018-07-27.
What interventions are being tested in trial NCT03110575?
The interventions under investigation include: TNX-102 SL (DRUG).
Who is sponsoring clinical trial NCT03110575?
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 NCT03110575's enrollment target sits among peer trials
190 1402nd of 2000 higher than 593 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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