Study of BXCL501 In Agitation Associated With Delirium in ICU Patients

• Status: Withdrawn
• Trial end date: 2022-02-21
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioXcel Therapeutics Inc
• Collaborator: Cognitive Research Corporation
• Treatments: Dexmedetomidine

Criteria

Inclusion Criteria:

Inclusion Criteria for Enrollment (Informed Consent):

1. ICU admitted male and female patients, ≥ 18 years, COVID 19 (+) and (-)

2. Subject or legally appointed representative (LAR) able to read, understand and provide informed consent, or to provide assent

Inclusion Criteria for Randomization:

3. Positive CAM-ICU

4. RASS score ≥ +1

5. Subject judged to be likely capable of self-administration

Exclusion Criteria:

1. Clinically significant ECG changes, brady- and tachyarrhythmias, QTc prolongation

2. Hepatic dysfunction

3. Pregnancy

4. Known allergy to Dexmedetomidine or Haloperidol.