Study of BXCL501 In Agitation Associated With Delirium in ICU Patients

NCT05313386 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: BXCL501-202
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Agitation; Delirium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The time to which a 2-point drop is seen in RASS score after starting dose administration

  24 Hours

• Overall delirium improvement as measured by the CAM-ICU-7 Total Score during ICU stay

  24 Hours

Study Arms (4)

Cohort 1- 120 Micrograms

EXPERIMENTAL

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.

Drug: BXCL501; Drug: Placebo film

Cohort 2- 180 Micrograms

EXPERIMENTAL

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.

Drug: BXCL501; Drug: Placebo film

Cohort 3- 240 Micrograms

EXPERIMENTAL

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.

Drug: BXCL501; Drug: Placebo film

Cohort 4- 300 Micrograms

EXPERIMENTAL

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.

Drug: BXCL501; Drug: Placebo film

Interventions

BXCL501 DRUG

BXCL501 is given in a film form

Also known as: Dexmedetomidine

Cohort 1- 120 Micrograms; Cohort 2- 180 Micrograms; Cohort 3- 240 Micrograms; Cohort 4- 300 Micrograms

Placebo film DRUG

Placebo is given in a film form

Cohort 1- 120 Micrograms; Cohort 2- 180 Micrograms; Cohort 3- 240 Micrograms; Cohort 4- 300 Micrograms

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Positive CAM-ICU
• RASS score ≥ +1
• Subject judged to be likely capable of self-administration

You may not qualify if:

• Clinically significant ECG changes, brady- and tachyarrhythmias, QTc prolongation
• Hepatic dysfunction
• Pregnancy
• Known allergy to Dexmedetomidine or Haloperidol.

Sponsors & Collaborators

• BioXcel Therapeutics Inc: lead
• Cognitive Research Corporation: collaborator

Study Sites (1)

BioXcel Clinical Research Site

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Psychomotor Agitation; Delirium

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Confusion; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomized, double-blind, placebo-controlled
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Cohorts will be enrolled sequentially in this dose escalating design.

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 6, 2022
• Study Start: February 23, 2021
• Primary Completion: February 21, 2022
• Study Completion: February 21, 2022
• Last Updated: April 6, 2022

Record last verified: 2022-04

Locations

US (1)