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BXCL501 for Agitation in the Emergency Department
NCT05974527Phase 4
Key facts
- Status
- Withdrawn
- Start
- Sep 2023
- Primary completion
- Sep 2025
- Sponsor
- Brigham and Women's Hospital
- Modality
- Small Molecules
- Drugs
- dexmedetomidine
- Conditions
- agitation
01
Overview
Phase 4, open-label, single-arm trial of dexmedetomidine in agitation, sponsored by Brigham and Women's Hospital. Primary endpoint: Altered Mental Status Scale at 120 minutes. Planned start Sep 2023; status: withdrawn.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Intervention - BXCL501
Participants receive sublingual film containing dexmedetomidine (BXCL501).
03
Who it enrols
Adults with an established diagnosis of bipolar disorder or schizophrenia spectrum disorders presenting to the ED with acute agitation (AMSS >= 2). Excludes patients with hypotension, bradycardia, or recent use of benzodiazepines/antipsychotics.
04
Endpoints
Primary
Altered Mental Status Scale
Secondary
Richmond Agitation Sedation Scale
Behavioral Activity Rating Scale
Broset Violence Checklist
Time to adequate sedation defined as AMSS <1
Time to adequate sedation defined as RASS <1
Time to adequate sedation defined as BARS <5
Time to adequate sedation defined as BVC <1
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