Trial intelligence / Profile preview

OASIS: TNX-102 SL for Acute Stress Reaction and PTSD Prevention

NCT06636786Phase 2

Key facts

Status: Recruiting
Start: Mar 2025
Primary completion: Nov 2026
Countries: 1
Sponsor: University of North Carolina at Chapel Hill
Modality: Small Molecules

Drugs: Tonmya
Conditions: acute stress reaction (ASR)acute stress disorder (ASD)post-traumatic stress disorder (PTSD)

Overview

Phase 2, randomised, double-blind trial in acute stress reaction (ASR), acute stress disorder (ASD) and post-traumatic stress disorder (PTSD) comparing Cyclobenzaprine HCl with Placebo (2 arms). Primary endpoint: Change in Acute Stress Disorder Score at 3 weeks. Started Mar 2025; status: recruiting.

Design

2 arms

Study design: RandomizedDouble-blind

Cyclobenzaprine HCl
TNX-102 SL sublingual tablets
Placebo
Placebo sublingual tablets

Who it enrols

Adults aged 18-55 presenting to the ED within 72 hours of a motor vehicle collision with pain severity >= 4, who are anticipated to be discharged home. Excludes patients with substantial comorbid injuries, chronic opioid use, severe psychiatric disorders, significant cardiovascular, hepatic, or renal disease, and those taking prohibited medications like MAOIs, SSRIs, SNRIs, or muscle relaxants.

Endpoints

Primary

Change in Acute Stress Disorder Score3 weeks

Secondary

Median reaction time of correct responses (general cognitive function)12 weeks
Median reaction time of correct responses (procedural reaction time)12 weeks
Proportion of targets correctly identified (visuospatial processing and attention)12 weeks
d-prime identification (psychomotor vigilance)12 weeks
Change in Pain Symptom Score12 weeks
Change in Depressive Symptoms Score12 weeks
Change in Somatic Symptom Score12 weeks
Change in PTSD Symptoms12 weeks

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