Agitation, Delirium
Conditions
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.
Interventions
DRUGBXCL501
BXCL501 is given in a film form
DRUGPlacebo film
Placebo is given in a film form
Sponsors
BioXcel Therapeutics Inc
Cognitive Research Corporation
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Randomized, double-blind, placebo-controlled
Intervention model description
Cohorts will be enrolled sequentially in this dose escalating design.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2-point or greater drop in RASS | 120 minutes | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The time to which a 2-point drop is seen in RASS score after starting dose administration | 24 Hours | The time to which a 2-point drop is seen in RASS score after starting dose administration. |
| Overall delirium improvement as measured by the CAM-ICU-7 Total Score during ICU stay | 24 Hours | Overall delirium improvement as measured by the CAM-ICU-7 Total Score during ICU stay |
Countries
United States
Contacts
STUDY_CHAIRBioXcel MM, MD
BioXcel Therapeutics
Outcome results
None listed