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NCT06636786 · ClinicalTrials.gov registry record · Phase 2
Prevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzaprine HCl (TNX-102 SL)
A Phase 2 study of Acute Stress Disorder and Neurocognitive Function, sponsored by University of North Carolina, Chapel Hill.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 180
- Enrollment target
- 6
- Study locations
NCT06636786 is a Phase 2 study of Acute Stress Disorder and Neurocognitive Function that is actively recruiting participants, run by University of North Carolina, Chapel Hill. The registered enrollment target is 180 participants, above the 148-participant average among 3 other Acute Stress Disorder trials with a reported enrollment target (22% higher). The trial reports 6 study locations across 5 states.
The verdict
NCT06636786, a Phase 2 study of Acute Stress Disorder and Neurocognitive Function, is actively recruiting participants, sponsored by University of North Carolina, Chapel Hill.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 180 participants
- Enrollment target
- 6
- Study locations
Study Summary
This study will examine the safety and efficacy of TNX-102 SL to reduce ASR symptoms and behavioral changes among patients presenting to the emergency department (ED) after motor vehicle collision (MVC). Specifically, the investigators will perform the Optimizing Acute Stress reaction Interventions with TNX-102 SL (OASIS) Trial, a double-blind placebo-controlled randomized clinical trial (RCT) to determine if TNX-102 SL initiated in the ED in the hours after MVC to high risk individuals, treats/reduces acute stress reaction (ASR)/acute stress disorder (ASD) symptoms (primary outcome), improves neurocognitive function, and prevents/reduces posttraumatic stress (PTS) symptoms (secondary outcomes) long term. 180 participants will be randomized, receive study drug in ED and be discharged with a 2-week drug supply. Prior to initial dose of study drug administration, and during the hours, days, and weeks after participants will receive serial longitudinal assessments of psychological and somatic symptoms, neurocognitive function, and adverse events.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Cyclobenzaprine HCl
Study Locations (6)
Rhode Island
- Rhode Island Hospital - Providence
- The Miriam Hospital - Providence
Indiana
- Indiana University - Indianapolis
Kansas
- University of Kansas Medical Center - Kansas City
Massachusetts
- University of Massachusetts Chan Medical School (Umass Memorial Medical Center) - Worcester
Missouri
- Washington University in St. Louis - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2025-03-25 |
| Est. Completion | 2025-09 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06636786
The ClinicalTrials.gov registry entry for NCT06636786 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 148-participant average among 3 other Acute Stress Disorder trials with a reported enrollment target (22% higher). The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Acute Stress Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06636786 reports 6 study locations spanning 5 distinct geographic areas - top geographies include Rhode Island, Indiana, Kansas.
Frequently Asked Questions
What is clinical trial NCT06636786 about?
NCT06636786 is a clinical study titled "Prevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzaprine HCl (TNX-102 SL)". This study will examine the safety and efficacy of TNX-102 SL to reduce ASR symptoms and behavioral changes among patients presenting to the emergency department (ED) after motor vehicle collision (MVC). Specifically, the investigators will perform the Optimizing Acute Stress reaction Interventions ...
What is the current status of trial NCT06636786?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 180 participants. The study started on 2025-03-25. Estimated completion is 2025-09.
What conditions does trial NCT06636786 study?
This clinical trial studies the following conditions: Acute Stress Disorder, Neurocognitive Function, Acute Stress Reaction, Post-traumatic Stress.
What interventions are being tested in trial NCT06636786?
The interventions under investigation include: Placebo (DRUG), Cyclobenzaprine HCl (DRUG).
Who is sponsoring clinical trial NCT06636786?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06636786 being conducted?
This trial has 6 study locations across Indiana, Kansas, Massachusetts, Missouri, Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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