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Prevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzaprine HCl (TNX-102 SL)

Study acronym: OASIS
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 116 words Site details revised at 1 of 9 sitesv6 Show 1 more changeShow less
    • Site details revised at 1 of 9 sites

    See this version in full on ClinicalTrials.gov ↗

  2. Primary and study completion dates: Sep 2025 to Sep 2026 Study sites: 6 to 9 · Eligibility criteria expanded, about 7 wordsv5 Show 2 more changesShow less
    • Study sites: 6 to 9
    • Eligibility criteria expanded, about 7 words

    See this version in full on ClinicalTrials.gov ↗

  3. Site details revised at 3 of 6 sitesv4
  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jan 2025 to Mar 25, 2025 · Eligibility criteria expanded, about 10 words · Site details revised at 6 of 6 sitesv3 Show 3 more changesShow less
    • Start date changed from estimate of Jan 2025 to Mar 25, 2025
    • Eligibility criteria expanded, about 10 words
    • Site details revised at 6 of 6 sites

    See this version in full on ClinicalTrials.gov ↗

  5. Start date: Oct 2024 to Jan 2025v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov