Clinical trial NCT05313386: Study of BXCL501 In Agitation Associated With Delirium in ICU Patients
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.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Agitation
Delirium
Lead sponsor: BioXcel Therapeutics Inc
Sponsor class: INDUSTRY
Collaborators: name: Cognitive Research Corporation
First posted: 2022-04-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Cohorts will be enrolled sequentially in this dose escalating design.
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: 2-point or greater drop in RASS
timeFrame: 120 minutes
Secondary outcomes:
measure: The time to which a 2-point drop is seen in RASS score after starting dose administration
timeFrame: 24 Hours
measure: Overall delirium improvement as measured by the CAM-ICU-7 Total Score during ICU stay
timeFrame: 24 Hours
Other outcomes:
Locations:
city: Nashville
country: United States
facility: BioXcel Clinical Research Site
state: Tennessee
Study officials:
References: