AgitationPhase 3NCT05271552
Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY II)
A Phase 3 study testing BXCL501 in people with Agitation and Dementia, run by BioXcel Therapeutics Inc at 11 sites in United States.
Trial summary
A study to determine the safety and efficacy of BXCL501 dosing for episodes of agitation associated with dementia when they occur (given as needed [PRN]), for a maximum of 28 doses within a 12-week treatment period. Read more about this study
- Who is it for?
- Ages 65 years and older
- What is being tested?
- BXCL501
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 151 participants
- Where
- 11 sitesUnited States
- Study dates
- 27 Apr 2022to 21 Apr 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- All subjects must have a diagnosis of probable AD based on NIA-AA criteria (2018)
- Episodes of psychomotor agitation (e.g., kick, bite, flailing)
- Subjects exhibit behaviors that are congruent with the International Psychogeriatric Association criterion for agitation representing a change from the subject's usual behavior
- A score of 15 to 23 on the Mini-Mental State Exam (MMSE)
- Subjects who read, understand, and provide written informed consent, or who have a LAR to provide consent on their behalf
- Subjects who are deemed to be medically appropriate for study participation by the principal investigator
- Participants who agree to use a medically acceptable and effective birth control method
Who cannot join
- Subjects with dementia or other memory impairment not due to probable AD.
- Clinical diagnosis of probable AD should not be applied when there is evidence of a cerebrovascular incident temporally related to the worsening of cognitive function.
- Subjects with agitation caused by acute intoxication.
- Subjects with significant risk of suicide or homicide per the investigator's assessment.
- Subjects who are medically unstable or in recovery. Note: Subjects with a remote (>5 years) history of stroke may be included, regardless of size/location.
- History of clinically significant syncope or syncopal attacks, orthostatic hypotension within the past 2 years, current evidence of hypovolemia, orthostatic hypotension, bradycardia.
Show all 10Show fewer
- Subjects who had a total score of >13 (ie, high fall risk) on the John Hopkins Fall Risk Assessment Tool.
- Subjects with laboratory or ECG abnormalities.
- Subjects who have received an investigational drug within 30 days prior to Screening.
- Subjects who are currently suffering from substance abuse. Patients with a potential cause for delirium (relatively recent onset agitation and dementia)
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
BioXcel Clinical Research Site
Berlin, New Jersey, 08009
BioXcel Clinical Research Site
Daytona Beach, Florida, 32117
BioXcel Clinical Research Site
Lady Lake, Florida, 32159
BioXcel Clinical Research Site
Long Beach, California, 90806
BioXcel Clinical Research Site
Maitland, Florida, 32751
BioXcel Clinical Research Site
Marrero, Louisiana, 70072
BioXcel Clinical Research Site
Miami Lakes, Florida, 33016
BioXcel Clinical Research Site
North Miami, Florida, 33161
BioXcel Clinical Research Site
Phoenix, Arizona, 85016
BioXcel Clinical Research Site
Springfield, Massachusetts, 01103
BioXcel Clinical Research Site
Toms River, New Jersey, 08755
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy And Safety Study of PRN Dosing of BXCL501 Over A 12 Week Period In Subjects With Agitation Associated With Dementia
A study to determine the safety and efficacy of BXCL501 dosing for episodes of agitation associated with dementia when they occur (given as needed [PRN]), for a maximum of 28 doses within a 12-week treatment period.
Read the detailed description
A randomized, double-blind, placebo-controlled, parallel group, 3-arm study assessing efficacy, safety, and tolerability of two doses of BXCL501 in male and female subjects (65 years and older) with acute psychomotor agitation. Subjects will be dosed PRN with a maximum of 28 doses over a 12-week period. Once a subject has received 28 doses of BXCL501, they will continue to be followed for the remainder of the 12-week study period.
Approximately 150 subjects will participate in this study. Subjects will receive a single film consisting of BXCL501 40 µg dose or BXCL501 60 µg dose or placebo in a 1:1:1 randomization scheme. Subjects must reside in a care facility where all study-related procedures and study drug dosing will be performed.
- Being tested
- BXCL501, Matching Placebo
- Medical subject headings
- Psychomotor Agitation, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BXCL501Drug
Also called Dexmedetomidine
Sublingual Film
Matching PlaceboDrug
Also called Placebo
Sublingual Placebo Film
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1- 40 Micrograms | Experimental | Sublingual film containing 40 Micrograms Dexmedetomidine Receives: Drug: BXCL501 |
| Cohort 2- 60 Micrograms | Experimental | Sublingual film containing 60 Micrograms Dexmedetomidine Receives: Drug: BXCL501 |
| Placebo | Placebo comparator | Sublingual Placebo film Receives: Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score for the First Episode of Agitation
The Positive and Negative Syndrome Scale - Excited Component (PEC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The PEC, the sum of these 5 subscales, thus ranges from 5 (absence of agitation) to 35 (extremely severe)
Measured: 120 minutes
Secondary outcomes (3)
Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited for the First Episode of Agitation
The Positive and Negative Syndrome Scale - Excited Component (PEC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The PEC, the sum of these 5 subscales, thus ranges from 5 (absence of agitation) to 35 (extremely severe)
Measured: 30 minutes
Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited for the First Episode of Agitation
The Positive and Negative Syndrome Scale - Excited Component (PEC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The PEC, the sum of these 5 subscales, thus ranges from 5 (absence of agitation) to 35 (extremely severe)
Measured: 60 minutes
Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited for All Episodes of Agitation
The Positive and Negative Syndrome Scale - Excited Component (PEC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The PEC, the sum of these 5 subscales, thus ranges from 5 (absence of agitation) to 35 (extremely severe)
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start27 Apr 2022
- Primary completion21 Apr 2023
- Study completion21 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 151 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
- NCT05271552
- Sponsor's protocol ID
- BXCL501-303
- Status last verified
- Aug 2026
- First submitted
- 28 Feb 2022
- Last updated
- 11 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy And Safety Study of PRN Dosing of BXCL501 Over A 12 Week Period In Subjects With Agitation Associated With Dementia
- ClinicalTrials.gov ID
- NCT05271552
- Acronym / sponsor ID
- BXCL501-303
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- BioXcel Therapeutics IncIndustry (pharma, biotech, devices)
- Collaborators
- Cognitive Research Corporation
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- 21 Apr 2023 (actual)
- Study completion
- 21 Apr 2023 (actual)
- First posted
- 9 Mar 2022 (actual)
- Results
- Posted 31 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to determine the safety and efficacy of BXCL501 dosing for episodes of agitation associated with dementia when they occur (given as needed [PRN]), for a maximum of 28 doses within a 12-week treatment period.
Detailed description
A randomized, double-blind, placebo-controlled, parallel group, 3-arm study assessing efficacy, safety, and tolerability of two doses of BXCL501 in male and female subjects (65 years and older) with acute psychomotor agitation. Subjects will be dosed PRN with a maximum of 28 doses over a 12-week period. Once a subject has received 28 doses of BXCL501, they will continue to be followed for the remainder of the 12-week study period.
Approximately 150 subjects will participate in this study. Subjects will receive a single film consisting of BXCL501 40 µg dose or BXCL501 60 µg dose or placebo in a 1:1:1 randomization scheme. Subjects must reside in a care facility where all study-related procedures and study drug dosing will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized
| Arm | Type | Receives |
|---|---|---|
| Cohort 1- 40 Micrograms | Experimental | Drug: BXCL501Sublingual film containing 40 Micrograms Dexmedetomidine |
| Cohort 2- 60 Micrograms | Experimental | Drug: BXCL501Sublingual film containing 60 Micrograms Dexmedetomidine |
| Placebo | Placebo comparator | Drug: Matching PlaceboSublingual Placebo film |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- All subjects must have a diagnosis of probable AD based on NIA-AA criteria (2018)
- Episodes of psychomotor agitation (e.g., kick, bite, flailing)
- Subjects exhibit behaviors that are congruent with the International Psychogeriatric Association criterion for agitation representing a change from the subject's usual behavior
- A score of 15 to 23 on the Mini-Mental State Exam (MMSE)
- Subjects who read, understand, and provide written informed consent, or who have a LAR to provide consent on their behalf
Key exclusion criteria (10 listed)
- Subjects with dementia or other memory impairment not due to probable AD.
- Clinical diagnosis of probable AD should not be applied when there is evidence of a cerebrovascular incident temporally related to the worsening of cognitive function.
- Subjects with agitation caused by acute intoxication.
- Subjects with significant risk of suicide or homicide per the investigator's assessment.
- Subjects who are medically unstable or in recovery. Note: Subjects with a remote (>5 years) history of stroke may be included, regardless of size/location.
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: DexmedetomidineSublingual Film | Drug | Cohort 1- 40 Micrograms, Cohort 2- 60 Micrograms |
| Matching PlaceboAlso: PlaceboSublingual Placebo Film | Drug | Placebo |
Primary outcome
Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score for the First Episode of Agitation
Time frame: 120 minutes
The Positive and Negative Syndrome Scale - Excited Component (PEC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The PEC, the sum of these 5 subscales, thus ranges from 5 (absence of agitation) to 35 (extremely severe)
3 secondary outcomes
Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited for the First Episode of Agitation
Time frame: 30 minutes
Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited for the First Episode of Agitation
Time frame: 60 minutes
Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited for All Episodes of Agitation
Time frame: 120 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Agitation
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 2/3
Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Alzheimer's Disease Dementia
Agitation Associated With Alzheimer's Disease Dementia
RecruitingPhase 3
Nabilone for Agitation Blinded Intervention Trial
Alzheimer Disease, Agitation
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
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
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BXCL501 in people with Agitation and Dementia, run by BioXcel Therapeutics Inc at 11 sites 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 7 inclusion and 10 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: finished, 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 11 sites 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score for the First Episode of Agitation (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.