Status:
WITHDRAWN
Study of BXCL501 In Agitation Associated With Delirium in ICU Patients
Lead Sponsor:
BioXcel Therapeutics Inc
Collaborating Sponsors:
Cognitive Research Corporation
Conditions:
Agitation
Delirium
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ascen...
Detailed Description
This is a Phase 2, randomized, double-blind, placebo-controlled, ascending starting dose finding study assessing safety, efficacy, tolerability and PK of BXCL501 in four starting dose cohort groups to...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Enrollment (Informed Consent):
- ICU admitted male and female patients, ≥ 18 years, COVID 19 (+) and (-)
- Subject or legally appointed representative (LAR) able to read, understand and provide informed consent, or to provide assent
- Inclusion Criteria for Randomization:
- Positive CAM-ICU
- RASS score ≥ +1
- Subject judged to be likely capable of self-administration
Exclusion
- Clinically significant ECG changes, brady- and tachyarrhythmias, QTc prolongation
- Hepatic dysfunction
- Pregnancy
- Known allergy to Dexmedetomidine or Haloperidol.
Key Trial Info
Start Date :
February 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05313386
Start Date
February 23 2021
End Date
February 21 2022
Last Update
April 6 2022
Active Locations (1)
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1
BioXcel Clinical Research Site
Nashville, Tennessee, United States, 37203