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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: Recruiting Phase 2 study, sponsored by University of North Carolina, Chapel Hill.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Individuals are asked to complete the 14-item Acute Stress Disorder Scale (ASDS) self-report inventory where each item is rated on a 5-point scale (0= Not at all; 1= Mildly; 2= Medium; 3= Quite a bit; 4= Very Much) that indexes acute stress disorder (ASD). Range of possible total scores is 0-56, with higher total scores indicating greater acute stress symptoms.
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 |
What NCT06943404 shows while recruiting
NCT06943404 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT06943404 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06943404's enrollment target sits among peer trials
100 672nd of 2000 higher than 1,263 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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