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CompletedNCT05271552Updated Aug 11, 2026Results posted

Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY II)

A Phase 3 interventional study of BXCL501 and Matching Placebo in Agitation and Dementia, sponsored by BioXcel Therapeutics Inc. Completed at 11 sites in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-08-11.

Sponsored by BioXcel Therapeutics Inc · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
151
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Agitation
  • Dementia
03

In context

Psychomotor Agitation

500 studies on the registry are indexed under Psychomotor Agitation; 55 are open to participants now.

This study's enrollment of 151 is above the median of 90 across 413 interventional studies indexed under Psychomotor Agitation.

Browse Psychomotor Agitation studies →

Lead sponsor

BioXcel Therapeutics Inc is the lead sponsor of 15 studies on the registry; 1 is open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 8 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. All subjects must have a diagnosis of probable AD based on NIA-AA criteria (2018)
  2. Episodes of psychomotor agitation (e.g., kick, bite, flailing)
  3. Subjects exhibit behaviors that are congruent with the International Psychogeriatric Association criterion for agitation representing a change from the subject's usual behavior
  4. A score of 15 to 23 on the Mini-Mental State Exam (MMSE)
  5. Subjects who read, understand, and provide written informed consent, or who have a LAR to provide consent on their behalf
  6. Subjects who are deemed to be medically appropriate for study participation by the principal investigator
  7. Participants who agree to use a medically acceptable and effective birth control method

Exclusion criteria

Exclusion Criteria:

  1. Subjects with dementia or other memory impairment not due to probable AD.
  2. 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.
  3. Subjects with agitation caused by acute intoxication.
  4. Subjects with significant risk of suicide or homicide per the investigator's assessment.
  5. 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.
  6. History of clinically significant syncope or syncopal attacks, orthostatic hypotension within the past 2 years, current evidence of hypovolemia, orthostatic hypotension, bradycardia.
  7. Subjects who had a total score of >13 (ie, high fall risk) on the John Hopkins Fall Risk Assessment Tool.
  8. Subjects with laboratory or ECG abnormalities.
  9. Subjects who have received an investigational drug within 30 days prior to Screening.
  10. Subjects who are currently suffering from substance abuse. Patients with a potential cause for delirium (relatively recent onset agitation and dementia)
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
151 participants (actual)

Study arms

  • Experimental
    Cohort 1- 40 Micrograms

    Sublingual film containing 40 Micrograms Dexmedetomidine

    Drug: BXCL501

  • Experimental
    Cohort 2- 60 Micrograms

    Sublingual film containing 60 Micrograms Dexmedetomidine

    Drug: BXCL501

  • Placebo comparator
    Placebo

    Sublingual Placebo film

    Drug: Matching Placebo

Interventions

  • DrugBXCL501

    Sublingual Film

    Also known as: Dexmedetomidine

  • DrugMatching Placebo

    Sublingual Placebo Film

    Also known as: Placebo

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 120 minutes

Secondary outcomes

  1. 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)

    Time frame: 30 minutes

  2. 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)

    Time frame: 60 minutes

  3. 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)

    Time frame: 120 minutes

07

Results

Posted Dec 31, 2025

Participant flow

The study was conducted in United States from 18 April 2022 to 21 April 2023.

Participant flow — Overall Study
MilestoneCohort 1- 40 MicrogramsCohort 2- 60 MicrogramsPlacebo
Started485053
Completed382932
Not completed102121
Withdrew: Adverse event463
Withdrew: Death111
Withdrew: Lost to follow-up154
Withdrew: Withdrawal by subject047
Withdrew: Other medical reason.120
Withdrew: Other336

Outcome measures

PrimaryAbsolute 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)

Time frame:
120 minutes
Reported as:
Least squares mean · score on a scale
Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score for the First Episode of Agitation
score on a scaleCohort 1- 40 MicrogramsCohort 2- 60 MicrogramsPlacebo
Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score for the First Episode of Agitation-5.7 ± 0.6-7.5 ± 0.6-5.4 ± 0.6
SecondaryAbsolute 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)

Time frame:
30 minutes
Reported as:
Least squares mean · score on a scale
Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited for the First Episode of Agitation
score on a scaleCohort 1- 40 MicrogramsCohort 2- 60 MicrogramsPlacebo
Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited for the First Episode of Agitation-2.5 ± 0.5-3.6 ± 0.5-3.4 ± 0.5
SecondaryAbsolute 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)

Time frame:
60 minutes
Reported as:
Least squares mean · score on a scale
Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited for the First Episode of Agitation
score on a scaleCohort 1- 40 MicrogramsCohort 2- 60 MicrogramsPlacebo
Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited for the First Episode of Agitation-4.2 ± 0.6-6.2 ± 0.6-4.2 ± 0.6
SecondaryAbsolute 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)

Time frame:
120 minutes
Reported as:
Least squares mean · score on a scale
Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited for All Episodes of Agitation
score on a scaleCohort 1- 40 MicrogramsCohort 2- 60 MicrogramsPlacebo
Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited for All Episodes of Agitation-5.8 ± 0.5-7.4 ± 0.5-5.2 ± 0.5

Adverse events

Collected over 24 hours after dose administration (treatment emergent adverse events). Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cohort 1- 40 Micrograms1/48 (2.1%)0/48 (0%)6/48 (12.5%)
Cohort 2- 60 Micrograms1/50 (2%)0/50 (0%)16/50 (32%)
Placebo1/51 (2%)0/51 (0%)2/51 (3.9%)
Most frequent other events
Showing 10 of 11
Most frequent other events
EventCohort 1- 40 MicrogramsCohort 2- 60 MicrogramsPlacebo
SomnolenceNervous system disorders2/483/500/51
HypotensionVascular disorders0/483/500/51
Orthostatic HypotensionVascular disorders2/482/500/51
BradycardiaCardiac disorders1/482/500/51
LethargyNervous system disorders1/481/500/51
DizzinessNervous system disorders0/481/501/51
DiarrhoeaGastrointestinal disorders0/481/500/51
Skin lacerationInjury, poisoning and procedural complications0/481/500/51
Wrist fractureInjury, poisoning and procedural complications0/481/500/51
Fracture treatmentSurgical and medical procedures0/481/500/51

Baseline characteristics

The Safety Population includes all subjects who received the study treatment. Two subjects randomized to Placebo voluntarily withdrew before dosed.

Age, Continuous
Age, Continuous(Years)Cohort 1- 40 MicrogramsCohort 2- 60 MicrogramsPlaceboTotal
Mean79.4 ± 6.4479.5 ± 8.1480.0 ± 7.4879.6 ± 7.35
Sex: Female, Male
Sex: Female, Male(Participants)Cohort 1- 40 MicrogramsCohort 2- 60 MicrogramsPlaceboTotal
Female27303390
Male21201859
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Cohort 1- 40 MicrogramsCohort 2- 60 MicrogramsPlaceboTotal
Hispanic or Latino18221959
Not Hispanic or Latino30283290
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Cohort 1- 40 MicrogramsCohort 2- 60 MicrogramsPlaceboTotal
American Indian or Alaska Native0000
Asian0000
Native Hawaiian or Other Pacific Islander0101
Black or African American1351129
White354339117
More than one race0000
Unknown or Not Reported0112
Baseline Positive and Negative Syndrome Scale - Excited Component (PEC)
Baseline Positive and Negative Syndrome Scale - Excited Component (PEC)(units on a scale)Cohort 1- 40 MicrogramsCohort 2- 60 MicrogramsPlaceboTotal
Mean17.3 ± 2.1818.0 ± 2.2617.5 ± 2.6217.6 ± 2.36
08

Study locations

11 sites
  • BioXcel Clinical Research Site
    Phoenix, Arizona 85016, United States
  • BioXcel Clinical Research Site
    Long Beach, California 90806, United States
  • BioXcel Clinical Research Site
    Daytona Beach, Florida 32117, United States
  • BioXcel Clinical Research Site
    Lady Lake, Florida 32159, United States
  • BioXcel Clinical Research Site
    Maitland, Florida 32751, United States
  • BioXcel Clinical Research Site
    Miami Lakes, Florida 33016, United States
  • BioXcel Clinical Research Site
    North Miami, Florida 33161, United States
  • BioXcel Clinical Research Site
    Marrero, Louisiana 70072, United States
  • BioXcel Clinical Research Site
    Springfield, Massachusetts 01103, United States
  • BioXcel Clinical Research Site
    Berlin, New Jersey 08009, United States
  • BioXcel Clinical Research Site
    Toms River, New Jersey 08755, United States
09

References and documents

Study documents

  • Study protocol · Nov 18, 2022
  • Statistical analysis plan · May 17, 2023

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05271552
Lead sponsor
BioXcel Therapeutics Inc
Collaborators
Cognitive Research Corporation
Responsible party
Sponsor
First posted
Mar 9, 2022
Start date
Apr 27, 2022
Primary completion
Apr 21, 2023
Completion
Apr 21, 2023
Results posted
Dec 31, 2025
Last update
Aug 11, 2026

Study contacts

BioXcel MM, MD
study chair · BioXcel Therapeutics

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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