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NCT02421679 · ClinicalTrials.gov registry record · Phase 2
Open Label Extension Safety and Efficacy Study of TNX-102 SL Tablets in Military Related PTSD and Related Conditions
A Phase 2 study of PTSD, sponsored by Tonix Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 159
- Enrollment target
- 20
- Study locations
NCT02421679: Completed Phase 2 study of PTSD, sponsored by Tonix Pharmaceuticals.
NCT02421679 is a Phase 2 study of PTSD that has completed, run by Tonix Pharmaceuticals. The registered enrollment target is 159 participants, below the 301-participant average among 154 other PTSD trials with a reported enrollment target (47% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02421679, a Phase 2 study of PTSD, has completed, sponsored by Tonix Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 159 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a 12-week, multicenter, open-label extension study to evaluate the safety and efficacy of TNX-102 SL tablet taken daily at bedtime in patients with Military-Related PTSD or related condition. Patients recruited into this trial are those who have successfully completed the double-blind study, TNX-CY-P201 (AtEase Study) \[NCT02277704\]. Patients will not be made aware of the therapy they received during the double-blind study.
Primary Outcome
Number of patients with new treatment emergent AEs since completing lead-in study
Conditions Studied
Interventions
- DRUG TNX-102 SL
Study Locations (20)
California
- Sun Valley Research Center - Imperial
- Synergy Clinical Research - National City
- Excell Research, Inc - Oceanside
- Neuropsychiatric Research Center of Orange County - Orange
- CITRIALS - Riverside
- CESAMH - San Diego
- Cns, Inc. - Torrance
Florida
- Sarkis Clinical Trials - Lake City
- Compass Research North, LLC - Leesburg
- Clinical Neuroscience Solutions, Inc. - Orlando
Ohio
- University of Cincinnati College of Medicine - Cincinnati
- University Hospitals Case Medical Center - Cleveland
Alabama
- Tuscaloosa VA Medical Center - Tuscaloosa
Arizona
- Noesis Pharma - Phoenix
Georgia
- Atlanta Center For Medical Research - Atlanta
Illinois
- Great Lakes Clinical Trials - Chicago
Massachusetts
- Novex Clinical Research - New Bedford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 159 participants |
| Start Date | 2015-04-14 |
| Est. Completion | 2016-05-26 |
| Phase | Phase 2 |
What the finished NCT02421679 record still lists
NCT02421679 is an interventional study that assigns participants to a tested intervention. The registered 159 participants enrollment target is mid-sized for trials with a published cap, below the 301-participant average among 154 other PTSD trials with a reported enrollment target (47% lower).
The record links to 1 condition, with PTSD appearing as the primary indexed condition, and to 1 intervention - of which TNX-102 SL is the first listed.
NCT02421679 names 20 study sites across 11 states, led by California, Florida, Ohio.
Frequently Asked Questions
What is clinical trial NCT02421679 about?
NCT02421679 is a clinical study titled "Open Label Extension Safety and Efficacy Study of TNX-102 SL Tablets in Military Related PTSD and Related Conditions". This is a 12-week, multicenter, open-label extension study to evaluate the safety and efficacy of TNX-102 SL tablet taken daily at bedtime in patients with Military-Related PTSD or related condition. Patients recruited into this trial are those who have successfully completed the double-blind study,...
What is the current status of trial NCT02421679?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 159 participants. The study started on 2015-04-14. Estimated completion is 2016-05-26.
What conditions does trial NCT02421679 study?
This clinical trial studies the following conditions: PTSD.
What interventions are being tested in trial NCT02421679?
The interventions under investigation include: TNX-102 SL (DRUG).
Who is sponsoring clinical trial NCT02421679?
This trial is sponsored by Tonix Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02421679 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for PTSD
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02421679's enrollment target sits among peer trials
159 41st of 154 higher than 114 of 154 other PTSD trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other PTSD 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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