Study of BXCL501 In Agitation Associated With Delirium in ICU Patients

NCT ID: NCT05313386

Last Updated: 2022-04-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-23
• Study Completion Date: 2022-02-21

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 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

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 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.

Conditions

Agitation; Delirium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cohort 1- 120 Micrograms

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.

Group Type: EXPERIMENTAL

BXCL501

Intervention Type: DRUG

BXCL501 is given in a film form

Placebo film

Intervention Type: DRUG

Placebo is given in a film form

Cohort 2- 180 Micrograms

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.

Group Type: EXPERIMENTAL

BXCL501

Intervention Type: DRUG

BXCL501 is given in a film form

Placebo film

Intervention Type: DRUG

Placebo is given in a film form

Cohort 3- 240 Micrograms

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.

Group Type: EXPERIMENTAL

BXCL501

Intervention Type: DRUG

BXCL501 is given in a film form

Placebo film

Intervention Type: DRUG

Placebo is given in a film form

Cohort 4- 300 Micrograms

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.

Group Type: EXPERIMENTAL

BXCL501

Intervention Type: DRUG

BXCL501 is given in a film form

Placebo film

Intervention Type: DRUG

Placebo is given in a film form

Interventions

BXCL501

BXCL501 is given in a film form

Intervention Type: DRUG

Placebo film

Placebo is given in a film form

Intervention Type: DRUG

Other Intervention Names

Dexmedetomidine

Eligibility Criteria

Inclusion Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cognitive Research Corporation

INDUSTRY

Sponsor Role: collaborator

BioXcel Therapeutics Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

BioXcel Clinical Research Site

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

BXCL501-202

Identifier Type: -

Identifier Source: org_study_id