Study of BXCL501 In Agitation Associated With Delirium in ICU Patients

Delirium Clinical Trial

Official title:

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-controlled, Ascending Starting Dose Finding, Safety, and Efficacy Study of BXCL501 in Agitation Associated With Delirium in ICU Patients.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05313386
• Other study ID #: BXCL501-202
• Status: Withdrawn
• Phase: Phase 2
• Start date: February 23, 2021
• Est. completion date: February 21, 2022

Study information

• Verified date: April 2022
• Source: BioXcel Therapeutics Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 reduce agitation levels associated with delirium in patients within the ICU setting. Evaluation of four BXCL501 starting doses compared to placebo will be conducted according to the following ascending doses: Cohort 1 (120 μg or placebo); Cohort 2 (180 μg or placebo); Cohort 3 (240 μg or placebo); Cohort 4 (300 μg or placebo). For subjects 65 years of age and older, the starting doses in each cohort will be reduced 50% in line with the Precedex (reference drug) label. Safety, efficacy, and tolerability will be assessed throughout the treatment period at various timepoints. Subjects will receive the first starting dose (BXCL501 or placebo) when Baseline RASS score is ≥ +1. Repeat doses may be administered in increments of 120 μg every 3 to 6 hours post first dose (StartD) only if the RASS score remains ≥ +1. For subjects 65 years and older, repeat doses may start in increments of 60 μg every 3 to 6 hours post first dose only if RASS is still ≥+1.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 21, 2022
• Est. primary completion date: February 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Agitation
• Delirium
• Psychomotor Agitation

Intervention

Drug:
• BXCL501
BXCL501 is given in a film form
• Placebo film
Placebo is given in a film form

Locations

Country	Name	City	State
United States	BioXcel Clinical Research Site	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
BioXcel Therapeutics Inc	Cognitive Research Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-point or greater drop in RASS	Identification of the dose leading to a 2-point or greater drop in RASS at 2 hours after starting dose administration, with initial RASS not = -3	120 minutes
Secondary	The time to which a 2-point drop is seen in RASS score after starting dose administration	The time to which a 2-point drop is seen in RASS score after starting dose administration.	24 Hours
Secondary	Overall delirium improvement as measured by the CAM-ICU-7 Total Score during ICU stay	Overall delirium improvement as measured by the CAM-ICU-7 Total Score during ICU stay	24 Hours