Pilot Study 1: Efficacy and Safety of Sublingual Dexmedetomidine (BXCL501) for the Treatment of Agitation in the Emergency Department

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

September 1, 2023

Primary Completion Date

September 30, 2025

Study Completion Date

June 30, 2026

Conditions
AgitationSchizophreniaSchizoaffective DisorderSchizophreniform DisordersBipolar Disorder
Interventions
DRUG

Sublingual film containing dexmedetomidine (BXCL501)

Enrolled participants will receive an initial dose of BXCL501 180mcg. Following the FDA dosing suggestions, participants with mild or moderate hepatic impairment (Child-Pugh Class A or B) will receive a reduced initial dose of 120mcg and participants with severe hepatic impairment (Child-Pugh Class C) will receive a reduced initial dose of 90mcg. Geriatric patients (≥ 65 years old) will receive a reduced initial dose of 120mcg.

All Listed Sponsors
lead

Brigham and Women's Hospital

OTHER

NCT05974527 - Pilot Study 1: Efficacy and Safety of Sublingual Dexmedetomidine (BXCL501) for the Treatment of Agitation in the Emergency Department | Biotech Hunter | Biotech Hunter