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NCT06943404 · ClinicalTrials.gov registry record · Phase 2
BXCL501 After Stress to Increase Recovery Success
A Phase 2 study, sponsored by University of North Carolina, Chapel Hill.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
NCT06943404 is a Phase 2 study that is actively recruiting participants, run by University of North Carolina, Chapel Hill. The registered enrollment target is 100 participants.
The verdict
NCT06943404, a Phase 2 study, is actively recruiting participants, sponsored by University of North Carolina, Chapel Hill.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG BXCL501 (dexmedetomidine HCl)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2026-02-23 |
| Est. Completion | 2026-09-29 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06943404
The ClinicalTrials.gov registry entry for NCT06943404 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT06943404 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06943404 about?
NCT06943404 is a clinical study titled "BXCL501 After Stress to Increase Recovery Success". 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-cont...
What is the current status of trial NCT06943404?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2026-02-23. Estimated completion is 2026-09-29.
What interventions are being tested in trial NCT06943404?
The interventions under investigation include: Placebo (DRUG), BXCL501 (dexmedetomidine HCl) (DRUG).
Who is sponsoring clinical trial NCT06943404?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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