Study of BXCL501 Sublingual Film to Prevent and Reduce Acute Stress and PTSD Symptoms After Motor Vehicle Collisions

What this Trial Is About

This research aims to evaluate the safety and effectiveness of BXCL501, a sublingual film of dexmedetomidine hydrochloride, in reducing acute stress reaction ASR symptoms and behavioral changes in patients who visit the Emergency Department after a motor vehicle collision. The study focuses on high-risk individuals to see if this treatment can improve neurocognitive function and reduce posttraumatic stress symptoms over the long term. It involves a randomized, double-blind, placebo-controlled trial setting with 100 participants. Participants will receive either BXCL501 or a placebo, starting with an initial dose in the Emergency Department. Depending on timing, a second dose is taken either the same day or the following day at bedtime. After this, participants continue taking a dose each night before bedtime for 14 days. Both the active drug and placebo are administered sublingually under the tongue. During the study, participants will undergo repeated assessments of psychological symptoms, neurocognitive function, and side effects at various times from minutes to weeks after the collision. Researchers will monitor changes in acute stress disorder symptoms, cognitive reaction times, pain, depressive symptoms, somatic symptoms, and posttraumatic stress symptoms. The study aims to track safety and effectiveness over this period, with a total participation duration covering the initial Emergency Department visit and 14 days of treatment.

BXCL501 After Stress to Increase Recovery Success