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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02421679
The ClinicalTrials.gov registry entry for NCT02421679 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 159 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 301-participant average among 154 other PTSD trials with a reported enrollment target (47% lower). The listed sponsor is Tonix Pharmaceuticals, which has 23 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 11 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.