MedTrace Logo

Study of BXCL501 In Agitation Associated With Delirium in ICU Patients

NCT05313386 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-04-06

No results posted yet for this study

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

Interventions

DRUG

BXCL501

BXCL501 is given in a film form

DRUG

Placebo film

Placebo is given in a film form

Sponsors & Collaborators

  • Cognitive Research Corporation

    collaborator INDUSTRY

  • BioXcel Therapeutics Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-23
Primary Completion
2022-02-21
Completion
2022-02-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05313386 on ClinicalTrials.gov