Study of BXCL501 In Agitation Associated With Delirium in ICU Patients
Status:
Withdrawn
Trial end date:
2022-02-21
Target enrollment:
Participant gender:
Summary
This study is designed to determine and evaluate the optimal BXCL501 starting dose (StartD)
that will safely and effectively reduce agitation associated with delirium in ICU patients.
This is an ascending adaptive dose study evaluating the safety and efficacy of four potential
starting doses of BXCL501 (120 μg, 180 μg, 240 μg, and 300 μg) in reducing agitation levels
in adult ICU patients with delirium. For subjects 65 years of age and older, the potential
doses will be reduced 50% in line with the Precedex (reference drug) label. The purpose of
this clinical trial is to identify an optimally safe and effective BXCL501