NCT06943404

BXCL501 After Stress to Increase Recovery Success

Prevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With a Sublingual Formulation of Dexmedetomidine (BXCL501)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

U.S. military personnel are exposed to life-threatening traumatic events (e.g., intense firefights with multiple casualties) that result in acute stress reaction (ASR) symptoms (ICD-10) and posttraumatic stress (PTS). Similarly, acute and persistent stress symptoms, and related adverse posttraumatic neuropsychiatric sequelae, are also very common and cause a tremendous burden of suffering in civilian populations following exposure to life-threatening traumatic events (e.g., motor vehicle collision, violent or accidental death of a loved one, and assault). BXCL501 (dexmedetomidine HCl sublingual film) has been evaluated in multiple clinical trials across a range of medical conditions (dementia, schizophrenia, bipolar disorder, opioid use disorder), with an excellent safety profile, and evidence of efficacy with respect to decreasing agitation. This is promising for the treatment of ASRs, as agitation is a primary feature of ASRs in many individuals. Additionally, adrenergic hyperactivity is also a key characteristic of ASRs and contributes to the development of Posttraumatic Stress Disorder (PTSD). BXCL501 is known to decrease the activity of central noradrenergic neurons, suggesting a mechanistic pathway by which BXCL501 may improve outcomes for individuals at risk of ASR/ASD/PTSD. BXCL501 therefore holds significant promise as a treatment aimed at reducing ASR symptoms and related behavioral changes, enhancing resilience and improving warfighter performance, and reducing the frequency and severity of persistent/chronic PTS symptoms. This study will evaluate the safety and efficacy of BXCL501 in a population of trauma survivors at high risk for developing ASR, ASD, and PTSD symptoms, and may ultimately provide military personnel, veterans, and civilians with an important new treatment option to improve recovery, job performance, and quality of life when administered in the early aftermath of exposure to a traumatic stressor.

Conditions

• Acute Stress Reaction
• Acute Stress Disorder
• Post-traumatic Stress Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-02-23
• Primary completion: 2026-09-29
• Completion: 2026-09-29
• First posted: 2025-04-24
• Last updated: 2026-04-14

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study