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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.

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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

FieldValue
Enrollment Target 100 participants
Start Date 2026-02-23
Est. Completion 2026-09-29
Phase Phase 2

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.