AgitationPhase 2NCT05313386
Study of BXCL501 In Agitation Associated With Delirium in ICU Patients
A Phase 2 study testing BXCL501 in people with Agitation and Delirium, run by BioXcel Therapeutics Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- BXCL501
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2021to 21 Feb 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Clinically significant ECG changes, brady- and tachyarrhythmias, QTc prolongation
- Hepatic dysfunction
- Pregnancy
- Known allergy to Dexmedetomidine or Haloperidol.
Trial locations and contacts
1 site in 1 country.
United States1 site
BioXcel Clinical Research Site
Nashville, Tennessee, 37203
About this study
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.
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
Read the 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.
- Being tested
- BXCL501, Placebo film
- Medical subject headings
- Psychomotor Agitation, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BXCL501Drug
Also called Dexmedetomidine
BXCL501 is given in a film form
Placebo filmDrug
Placebo is given in a film form
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: BXCL501; Drug: Placebo film |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 120 minutes
Secondary outcomes (2)
The time to which a 2-point drop is seen in RASS score after starting dose administration
The time to which a 2-point drop is seen in RASS score after starting dose administration.
Measured: 24 Hours
Overall delirium improvement as measured by the CAM-ICU-7 Total Score during ICU stay
Overall delirium improvement as measured by the CAM-ICU-7 Total Score during ICU stay
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start23 Feb 2021
- Primary completion21 Feb 2022 (estimated)
- Study completion21 Feb 2022 (estimated)
Why it stopped: The study stopped early, before enrolling its first participant
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Cohorts will be enrolled sequentially in this dose escalating design.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioXcel Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cognitive Research Corporation
- Responsible party
- Sponsor
- Investigators
- BioXcel MM, MD, Study chair, BioXcel Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313386
- Sponsor's protocol ID
- BXCL501-202
- Status last verified
- Aug 2026
- First submitted
- 31 Mar 2021
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05313386
- Acronym / sponsor ID
- BXCL501-202
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study stopped early, before enrolling its first participant
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BioXcel Therapeutics IncIndustry (pharma, biotech, devices)
- Collaborators
- Cognitive Research Corporation
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 21 Feb 2022 (estimated)
- Study completion
- 21 Feb 2022 (estimated)
- First posted
- 6 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Cohorts will be enrolled sequentially in this dose escalating design.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1- 120 Micrograms | Experimental | Drug: BXCL501, Drug: Placebo film120 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. |
| Cohort 2- 180 Micrograms | Experimental | Drug: BXCL501, Drug: Placebo film180 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. |
| Cohort 3- 240 Micrograms | Experimental | Drug: BXCL501, Drug: Placebo filmTwo 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. |
| Cohort 4- 300 Micrograms | Experimental | Drug: BXCL501, Drug: Placebo filmOne 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Clinically significant ECG changes, brady- and tachyarrhythmias, QTc prolongation
- Hepatic dysfunction
- Pregnancy
- Known allergy to Dexmedetomidine or Haloperidol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BXCL501Also: DexmedetomidineBXCL501 is given in a film form | Drug | Cohort 1- 120 Micrograms, Cohort 2- 180 Micrograms, Cohort 3- 240 Micrograms, Cohort 4- 300 Micrograms |
| Placebo filmPlacebo is given in a film form | Drug | Cohort 1- 120 Micrograms, Cohort 2- 180 Micrograms, Cohort 3- 240 Micrograms, Cohort 4- 300 Micrograms |
Primary outcome
2-point or greater drop in RASS
Time frame: 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
2 secondary outcomes
The time to which a 2-point drop is seen in RASS score after starting dose administration
Time frame: 24 Hours
Overall delirium improvement as measured by the CAM-ICU-7 Total Score during ICU stay
Time frame: 24 Hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BioXcel MM, MD study chair
BioXcel Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BXCL501 in people with Agitation and Delirium, run by BioXcel Therapeutics Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-point or greater drop in RASS (time frame: 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.