Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Open Label Extension Safety and Efficacy Study of TNX-102 SL Tablets in Military Related PTSD and Related Conditions
NCT02421679 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 159 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tonix Pharmaceuticals, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02421679 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Florida, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02421679?
The interventions under investigation include: TNX-102 SL (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02421679?
This trial is sponsored by Tonix Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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