NCT05271552|CompletedPhase 3ResultsDMCFDA Drug

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

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

BioXcel Therapeutics Inc ClinicalTrials.gov

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1 other identifier

BXCL501-303

Study Type

interventional

Target

151

Locations

1 country

Sites

Timeline

RegisteredMar 2022

StartedApr 2022

CompletionApr 2023

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

151

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started Apr 2022

Shorter than P25 for phase_3

Geographic Reach

1 country

11 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

12 months study duration

First Submitted

Initial submission to the registry

February 28, 2022

Completed

9 days until next milestone

First Posted

Study publicly available on registry

March 9, 2022

Completed

2 months until next milestone

Study Start

First participant enrolled

April 27, 2022

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2023

Completed

2.7 years until next milestone

Results Posted

Study results publicly available

December 31, 2025

Completed

Last Updated

December 31, 2025

Status Verified

December 1, 2025

Enrollment Period

12 months

First QC Date

February 28, 2022

Results QC Date

November 7, 2025

Last Update Submit

December 11, 2025

Conditions

Agitation Dementia

Outcome Measures

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)
120 minutes

Secondary Outcomes (3)

Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited for the First Episode of Agitation
30 minutes
Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited for the First Episode of Agitation
60 minutes
Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited for All Episodes of Agitation
120 minutes

Study Arms (3)

Cohort 1- 40 Micrograms

EXPERIMENTAL

Sublingual film containing 40 Micrograms Dexmedetomidine

Drug: BXCL501

Cohort 2- 60 Micrograms

EXPERIMENTAL

Sublingual film containing 60 Micrograms Dexmedetomidine

Drug: BXCL501

Placebo

PLACEBO COMPARATOR

Sublingual Placebo film

Drug: Matching Placebo

Interventions

Matching PlaceboDRUG

Sublingual Placebo Film

Also known as: Placebo

Placebo

BXCL501DRUG

Sublingual Film

Also known as: Dexmedetomidine

Cohort 1- 40 MicrogramsCohort 2- 60 Micrograms

Eligibility Criteria

Age65 Years+

Sexall

Healthy VolunteersNo

Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

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.
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)

Contact the study team to confirm eligibility.