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NCT03508700 · ClinicalTrials.gov registry record · Phase 3
A 40-week Study to Evaluate TNX-102 SL 5.6 mg Taken Daily at Bedtime in Patients With PTSD
A Phase 3 study of PTSD, sponsored by Tonix Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 93
- Enrollment target
- 16
- Study locations
NCT03508700: Completed Phase 3 study of PTSD, sponsored by Tonix Pharmaceuticals.
NCT03508700 is a Phase 3 study of PTSD that has completed, run by Tonix Pharmaceuticals. The registered enrollment target is 93 participants, below the 301-participant average among 154 other PTSD trials with a reported enrollment target (69% lower). The trial reports 16 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03508700, a Phase 3 study of PTSD, has completed, sponsored by Tonix Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 93 participants
- Enrollment target
- 16
- Study locations
Study Summary
Evaluate the long-term safety of TNX-102 SL 5.6 mg taken daily at bedtime over an additional 40 weeks in patients with PTSD who have participated in a double-blind lead-in study and completed an initial 12-week open-label extension study (TNX-CY-P303).
Primary Outcome
Evaluate the incidence of newly emergent adverse events over an additional 40 weeks of treatment with TNX-102 SL 5.6 mg in patients with PTSD who have participated in a double-blinded lead-in study. 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. Serious AEs and AEs leading to discontinuation of study drug will also be summarized.
Conditions Studied
Interventions
- DRUG TNX-102 SL 5.6 mg
Study Locations (16)
California
- Beverly Hills - Beverly Hills
- Oceanside - Oceanside
- Orange - Orange
- Temecula - Temecula
New York
- Cedarhurst - Cedarhurst
- New York - New York
Ohio
- Canton - Canton
- Cincinnati - Cincinnati
Arkansas
- Little Rock - Little Rock
Colorado
- Colorado Springs - Colorado Springs
Connecticut
- Norwich - Norwich
Florida
- Tampa - Tampa
Georgia
- Atlanta - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2018-04-19 |
| Est. Completion | 2019-09-30 |
| Phase | Phase 3 |
What the finished NCT03508700 record still lists
NCT03508700 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, below the 301-participant average among 154 other PTSD trials with a reported enrollment target (69% lower).
The record links to 1 condition, with PTSD appearing as the primary indexed condition, and to 1 intervention - of which TNX-102 SL 5.6 mg is the first listed.
NCT03508700 lists 16 locations in 11 states (California, New York, Ohio).
Frequently Asked Questions
What is clinical trial NCT03508700 about?
NCT03508700 is a clinical study titled "A 40-week Study to Evaluate TNX-102 SL 5.6 mg Taken Daily at Bedtime in Patients With PTSD". Evaluate the long-term safety of TNX-102 SL 5.6 mg taken daily at bedtime over an additional 40 weeks in patients with PTSD who have participated in a double-blind lead-in study and completed an initial 12-week open-label extension study (TNX-CY-P303).
What is the current status of trial NCT03508700?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 93 participants. The study started on 2018-04-19. Estimated completion is 2019-09-30.
What conditions does trial NCT03508700 study?
This clinical trial studies the following conditions: PTSD.
What interventions are being tested in trial NCT03508700?
The interventions under investigation include: TNX-102 SL 5.6 mg (DRUG).
Who is sponsoring clinical trial NCT03508700?
This trial is sponsored by Tonix Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03508700 being conducted?
This trial has 16 study locations across Arkansas, California, Colorado, Connecticut, Florida. 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 NCT03508700's enrollment target sits among peer trials
93 68th of 154 higher than 87 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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