Study of BXCL501 In Agitation Associated With Delirium in ICU Patients

BioXcel Therapeutics

Status and phase: Withdrawn; Phase 2

Conditions: Delirium; Agitation

Treatments: Drug: BXCL501; Drug: Placebo film

Study type: Interventional

Funder types: Industry

Identifiers

NCT05313386

BXCL501-202

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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0 participants in 4 patient groups

Cohort 1- 120 Micrograms

Experimental group

Description:

120 Micrograms film or Placebo film are given to patients in 3:1 ratio respectively. 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.

Treatment:

Drug: Placebo film

Drug: BXCL501

Cohort 2- 180 Micrograms

Experimental group

Description:

180 Micrograms film or Placebo film are given to patients in 3:1 ratio respectively. 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.

Treatment:

Drug: Placebo film

Drug: BXCL501

Cohort 3- 240 Micrograms

Experimental group

Description:

Two 120 Micrograms films or two Placebo films are given to patients in 3:1 ratio respectively. 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.

Treatment:

Drug: Placebo film

Drug: BXCL501

Cohort 4- 300 Micrograms

Experimental group

Description:

One 120 Micrograms film and one 180 Micrograms film or two Placebo films are given to patients in 3:1 ratio respectively. 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.

Treatment:

Drug: Placebo film

Drug: BXCL501