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BXCL501 After Stress to Increase Recovery Success
Sponsor: University of North Carolina, Chapel Hill
Summary
This study will examine the safety and efficacy of BXCL501 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 BXCL501 (BASIS) Trial, a double-blind placebo-controlled Randomized Controlled Trial (RCT) to determine if BXCL501 (dexmedetomidine hydrochloride sublingual film) initiated in the ED in the hours after MVC to high risk individuals, treats/reduces ASR/ASD symptoms (primary outcome), improves neurocognitive function, and prevents/reduces posttraumatic stress (PTS) symptoms (secondary outcomes) long term. 100 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.
Official title: Prevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With a Sublingual Formulation of Dexmedetomidine (BXCL501)
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-02-11
Completion Date
2026-09-29
Last Updated
2026-02-11
Healthy Volunteers
No
Interventions
BXCL501 (dexmedetomidine HCl)
BXCL501 (dexmedetomidine HCl) taken sublingually (under the tongue) in the ED and at bedtime over 2 weeks.
Placebo
Placebo taken sublingually (under the tongue) in the ED and at bedtime over 2 weeks.
Locations (3)
University of Florida College of Medicine - Jacksonville
Jacksonville, Florida, United States
Washington University in St. Louis
St Louis, Missouri, United States
UVA University Hospital
Charlottesville, Virginia, United States