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NOT YET RECRUITING
NCT06943404
PHASE2

BXCL501 After Stress to Increase Recovery Success

Sponsor: University of North Carolina, Chapel Hill

View on ClinicalTrials.gov

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

DRUG

BXCL501 (dexmedetomidine HCl)

BXCL501 (dexmedetomidine HCl) taken sublingually (under the tongue) in the ED and at bedtime over 2 weeks.

DRUG

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