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 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.

NCT Number	NCT06636786
Lead Sponsor	University of North Carolina, Chapel Hill Collaborators: United States Department of Defense, Tonix Pharmaceuticals, Inc., Mclean Hospital, Cooper University Health Care
Conditions	Acute Stress Reaction, Acute Stress Disorder, Neurocognitive Function, Post-traumatic Stress
Enrollment	180 participants
Start Date	2025-03-25
Primary Completion	2026-09 (estimated)
Study Completion	2026-09 (estimated)
Updated on ClinicalTrials.gov	2026-04-13