Trial Outcomes & Findings for Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY II) (NCT NCT05271552)

Last Updated: 2025-12-31

Results Overview

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)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

151 participants

Primary outcome timeframe

120 minutes

Results posted on

2025-12-31

Participant Flow

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

Participant milestones

Participant milestones
Measure	Cohort 1- 40 Micrograms Sublingual film containing 40 Micrograms Dexmedetomidine BXCL501: Sublingual Film	Cohort 2- 60 Micrograms Sublingual film containing 60 Micrograms Dexmedetomidine BXCL501: Sublingual Film	Placebo Sublingual Placebo film Matching Placebo: Sublingual Placebo Film
Overall Study STARTED	48	50	53
Overall Study COMPLETED	38	29	32
Overall Study NOT COMPLETED	10	21	21

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1- 40 Micrograms Sublingual film containing 40 Micrograms Dexmedetomidine BXCL501: Sublingual Film	Cohort 2- 60 Micrograms Sublingual film containing 60 Micrograms Dexmedetomidine BXCL501: Sublingual Film	Placebo Sublingual Placebo film Matching Placebo: Sublingual Placebo Film
Overall Study Adverse Event	4	6	3
Overall Study Death	1	1	1
Overall Study Lost to Follow-up	1	5	4
Overall Study Withdrawal by Subject	0	4	7
Overall Study Other medical reason.	1	2	0
Overall Study Other	3	3	6

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1- 40 Micrograms n=48 Participants Sublingual film containing 40 Micrograms Dexmedetomidine BXCL501: Sublingual Film	Cohort 2- 60 Micrograms n=50 Participants Sublingual film containing 60 Micrograms Dexmedetomidine BXCL501: Sublingual Film	Placebo n=51 Participants Sublingual Placebo film Matching Placebo: Sublingual Placebo Film	Total n=149 Participants Total of all reporting groups
Ethnicity (NIH/OMB) Hispanic or Latino	18 Participants n=9 Participants	22 Participants n=6 Participants	19 Participants n=9 Participants	59 Participants n=205 Participants
Age, Continuous	79.4 Years STANDARD_DEVIATION 6.44 • n=9 Participants	79.5 Years STANDARD_DEVIATION 8.14 • n=6 Participants	80.0 Years STANDARD_DEVIATION 7.48 • n=9 Participants	79.6 Years STANDARD_DEVIATION 7.35 • n=205 Participants
Sex: Female, Male Female	27 Participants n=9 Participants	30 Participants n=6 Participants	33 Participants n=9 Participants	90 Participants n=205 Participants
Sex: Female, Male Male	21 Participants n=9 Participants	20 Participants n=6 Participants	18 Participants n=9 Participants	59 Participants n=205 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=9 Participants	28 Participants n=6 Participants	32 Participants n=9 Participants	90 Participants n=205 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants	0 Participants n=205 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants	0 Participants n=205 Participants
Race (NIH/OMB) Asian	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants	0 Participants n=205 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants	1 Participants n=6 Participants	0 Participants n=9 Participants	1 Participants n=205 Participants
Race (NIH/OMB) Black or African American	13 Participants n=9 Participants	5 Participants n=6 Participants	11 Participants n=9 Participants	29 Participants n=205 Participants
Race (NIH/OMB) White	35 Participants n=9 Participants	43 Participants n=6 Participants	39 Participants n=9 Participants	117 Participants n=205 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants	0 Participants n=205 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	1 Participants n=6 Participants	1 Participants n=9 Participants	2 Participants n=205 Participants
Baseline Positive and Negative Syndrome Scale - Excited Component (PEC)	17.3 units on a scale STANDARD_DEVIATION 2.18 • n=9 Participants	18.0 units on a scale STANDARD_DEVIATION 2.26 • n=6 Participants	17.5 units on a scale STANDARD_DEVIATION 2.62 • n=9 Participants	17.6 units on a scale STANDARD_DEVIATION 2.36 • n=205 Participants

PRIMARY outcome

Timeframe: 120 minutes

Population: Full analysis set included all subjects who took any study medication and who had both baseline and at least one efficacy assessment after dosing.

Outcome measures

Outcome measures
Measure	Cohort 1- 40 Micrograms n=48 Participants Sublingual film containing 40 Micrograms Dexmedetomidine BXCL501: Sublingual Film	Cohort 2- 60 Micrograms n=50 Participants Sublingual film containing 60 Micrograms Dexmedetomidine BXCL501: Sublingual Film	Placebo n=51 Participants Sublingual Placebo film Matching Placebo: Sublingual Placebo Film
Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score for the First Episode of Agitation	-5.7 score on a scale Standard Error 0.6	-7.5 score on a scale Standard Error 0.6	-5.4 score on a scale Standard Error 0.6

SECONDARY outcome

Timeframe: 30 minutes

Population: Full Analysis Set (FAS) included all subjects who took any study medication and who had both baseline and at least one efficacy assessment after dosing.

Outcome measures

Outcome measures
Measure	Cohort 1- 40 Micrograms n=48 Participants Sublingual film containing 40 Micrograms Dexmedetomidine BXCL501: Sublingual Film	Cohort 2- 60 Micrograms n=50 Participants Sublingual film containing 60 Micrograms Dexmedetomidine BXCL501: Sublingual Film	Placebo n=51 Participants Sublingual Placebo film Matching Placebo: Sublingual Placebo Film
Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited for the First Episode of Agitation	-2.5 score on a scale Standard Error 0.5	-3.6 score on a scale Standard Error 0.5	-3.4 score on a scale Standard Error 0.5

SECONDARY outcome

Timeframe: 60 minutes

Population: Full Analysis Set (FAS) included all subjects who took any study medication and who had both baseline and at least one efficacy assessment after dosing.

Outcome measures

Outcome measures
Measure	Cohort 1- 40 Micrograms n=48 Participants Sublingual film containing 40 Micrograms Dexmedetomidine BXCL501: Sublingual Film	Cohort 2- 60 Micrograms n=50 Participants Sublingual film containing 60 Micrograms Dexmedetomidine BXCL501: Sublingual Film	Placebo n=51 Participants Sublingual Placebo film Matching Placebo: Sublingual Placebo Film
Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited for the First Episode of Agitation	-4.2 score on a scale Standard Error 0.6	-6.2 score on a scale Standard Error 0.6	-4.2 score on a scale Standard Error 0.6

SECONDARY outcome

Timeframe: 120 minutes

Population: Full Analysis Set (FAS) included all subjects who took any study medication and who had both baseline and at least one efficacy assessment after dosing.

Outcome measures

Outcome measures
Measure	Cohort 1- 40 Micrograms n=48 Participants Sublingual film containing 40 Micrograms Dexmedetomidine BXCL501: Sublingual Film	Cohort 2- 60 Micrograms n=50 Participants Sublingual film containing 60 Micrograms Dexmedetomidine BXCL501: Sublingual Film	Placebo n=51 Participants Sublingual Placebo film Matching Placebo: Sublingual Placebo Film
Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited for All Episodes of Agitation	-5.8 score on a scale Standard Error 0.5	-7.4 score on a scale Standard Error 0.5	-5.2 score on a scale Standard Error 0.5

Adverse Events

Cohort 1- 40 Micrograms

Serious events: 0 serious events

Other events: 6 other events

Deaths: 1 deaths

Cohort 2- 60 Micrograms

Serious events: 0 serious events

Other events: 16 other events

Deaths: 1 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cohort 1- 40 Micrograms n=48 participants at risk Sublingual film containing 40 Micrograms Dexmedetomidine BXCL501: Sublingual Film	Cohort 2- 60 Micrograms n=50 participants at risk Sublingual film containing 60 Micrograms Dexmedetomidine BXCL501: Sublingual Film	Placebo n=51 participants at risk Sublingual Placebo film Matching Placebo: Sublingual Placebo Film
Nervous system disorders Lethargy	2.1% 1/48 • 24 hours after dose administration (treatment emergent adverse events) The AEs are summarized as treatment emergent adverse events which started within 24 hours after any dose. Subjects are counted once at the highest severity at each organ class and preferred term. The terms were coded using MedDRA, Version 25.0.	2.0% 1/50 • 24 hours after dose administration (treatment emergent adverse events) The AEs are summarized as treatment emergent adverse events which started within 24 hours after any dose. Subjects are counted once at the highest severity at each organ class and preferred term. The terms were coded using MedDRA, Version 25.0.	0.00% 0/51 • 24 hours after dose administration (treatment emergent adverse events) The AEs are summarized as treatment emergent adverse events which started within 24 hours after any dose. Subjects are counted once at the highest severity at each organ class and preferred term. The terms were coded using MedDRA, Version 25.0.
Nervous system disorders Dizziness	0.00% 0/48 • 24 hours after dose administration (treatment emergent adverse events) The AEs are summarized as treatment emergent adverse events which started within 24 hours after any dose. Subjects are counted once at the highest severity at each organ class and preferred term. The terms were coded using MedDRA, Version 25.0.	2.0% 1/50 • 24 hours after dose administration (treatment emergent adverse events) The AEs are summarized as treatment emergent adverse events which started within 24 hours after any dose. Subjects are counted once at the highest severity at each organ class and preferred term. The terms were coded using MedDRA, Version 25.0.	2.0% 1/51 • 24 hours after dose administration (treatment emergent adverse events) The AEs are summarized as treatment emergent adverse events which started within 24 hours after any dose. Subjects are counted once at the highest severity at each organ class and preferred term. The terms were coded using MedDRA, Version 25.0.
Nervous system disorders Somnolence	4.2% 2/48 • 24 hours after dose administration (treatment emergent adverse events) The AEs are summarized as treatment emergent adverse events which started within 24 hours after any dose. Subjects are counted once at the highest severity at each organ class and preferred term. The terms were coded using MedDRA, Version 25.0.	6.0% 3/50 • 24 hours after dose administration (treatment emergent adverse events) The AEs are summarized as treatment emergent adverse events which started within 24 hours after any dose. Subjects are counted once at the highest severity at each organ class and preferred term. The terms were coded using MedDRA, Version 25.0.	0.00% 0/51 • 24 hours after dose administration (treatment emergent adverse events) The AEs are summarized as treatment emergent adverse events which started within 24 hours after any dose. Subjects are counted once at the highest severity at each organ class and preferred term. The terms were coded using MedDRA, Version 25.0.
Vascular disorders Hypotension	0.00% 0/48 • 24 hours after dose administration (treatment emergent adverse events) The AEs are summarized as treatment emergent adverse events which started within 24 hours after any dose. Subjects are counted once at the highest severity at each organ class and preferred term. The terms were coded using MedDRA, Version 25.0.	6.0% 3/50 • 24 hours after dose administration (treatment emergent adverse events) The AEs are summarized as treatment emergent adverse events which started within 24 hours after any dose. Subjects are counted once at the highest severity at each organ class and preferred term. The terms were coded using MedDRA, Version 25.0.	0.00% 0/51 • 24 hours after dose administration (treatment emergent adverse events) The AEs are summarized as treatment emergent adverse events which started within 24 hours after any dose. Subjects are counted once at the highest severity at each organ class and preferred term. The terms were coded using MedDRA, Version 25.0.
Vascular disorders Orthostatic Hypotension	4.2% 2/48 • 24 hours after dose administration (treatment emergent adverse events) The AEs are summarized as treatment emergent adverse events which started within 24 hours after any dose. Subjects are counted once at the highest severity at each organ class and preferred term. The terms were coded using MedDRA, Version 25.0.	4.0% 2/50 • 24 hours after dose administration (treatment emergent adverse events) The AEs are summarized as treatment emergent adverse events which started within 24 hours after any dose. Subjects are counted once at the highest severity at each organ class and preferred term. The terms were coded using MedDRA, Version 25.0.	0.00% 0/51 • 24 hours after dose administration (treatment emergent adverse events) The AEs are summarized as treatment emergent adverse events which started within 24 hours after any dose. Subjects are counted once at the highest severity at each organ class and preferred term. The terms were coded using MedDRA, Version 25.0.
Cardiac disorders Bradycardia	2.1% 1/48 • 24 hours after dose administration (treatment emergent adverse events) The AEs are summarized as treatment emergent adverse events which started within 24 hours after any dose. Subjects are counted once at the highest severity at each organ class and preferred term. The terms were coded using MedDRA, Version 25.0.	4.0% 2/50 • 24 hours after dose administration (treatment emergent adverse events) The AEs are summarized as treatment emergent adverse events which started within 24 hours after any dose. Subjects are counted once at the highest severity at each organ class and preferred term. The terms were coded using MedDRA, Version 25.0.	0.00% 0/51 • 24 hours after dose administration (treatment emergent adverse events) The AEs are summarized as treatment emergent adverse events which started within 24 hours after any dose. Subjects are counted once at the highest severity at each organ class and preferred term. The terms were coded using MedDRA, Version 25.0.
Gastrointestinal disorders Diarrhoea	0.00% 0/48 • 24 hours after dose administration (treatment emergent adverse events) The AEs are summarized as treatment emergent adverse events which started within 24 hours after any dose. Subjects are counted once at the highest severity at each organ class and preferred term. The terms were coded using MedDRA, Version 25.0.	2.0% 1/50 • 24 hours after dose administration (treatment emergent adverse events) The AEs are summarized as treatment emergent adverse events which started within 24 hours after any dose. Subjects are counted once at the highest severity at each organ class and preferred term. The terms were coded using MedDRA, Version 25.0.	0.00% 0/51 • 24 hours after dose administration (treatment emergent adverse events) The AEs are summarized as treatment emergent adverse events which started within 24 hours after any dose. Subjects are counted once at the highest severity at each organ class and preferred term. The terms were coded using MedDRA, Version 25.0.
Injury, poisoning and procedural complications Fall	0.00% 0/48 • 24 hours after dose administration (treatment emergent adverse events) The AEs are summarized as treatment emergent adverse events which started within 24 hours after any dose. Subjects are counted once at the highest severity at each organ class and preferred term. The terms were coded using MedDRA, Version 25.0.	0.00% 0/50 • 24 hours after dose administration (treatment emergent adverse events) The AEs are summarized as treatment emergent adverse events which started within 24 hours after any dose. Subjects are counted once at the highest severity at each organ class and preferred term. The terms were coded using MedDRA, Version 25.0.	2.0% 1/51 • 24 hours after dose administration (treatment emergent adverse events) The AEs are summarized as treatment emergent adverse events which started within 24 hours after any dose. Subjects are counted once at the highest severity at each organ class and preferred term. The terms were coded using MedDRA, Version 25.0.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/48 • 24 hours after dose administration (treatment emergent adverse events) The AEs are summarized as treatment emergent adverse events which started within 24 hours after any dose. Subjects are counted once at the highest severity at each organ class and preferred term. The terms were coded using MedDRA, Version 25.0.	2.0% 1/50 • 24 hours after dose administration (treatment emergent adverse events) The AEs are summarized as treatment emergent adverse events which started within 24 hours after any dose. Subjects are counted once at the highest severity at each organ class and preferred term. The terms were coded using MedDRA, Version 25.0.	0.00% 0/51 • 24 hours after dose administration (treatment emergent adverse events) The AEs are summarized as treatment emergent adverse events which started within 24 hours after any dose. Subjects are counted once at the highest severity at each organ class and preferred term. The terms were coded using MedDRA, Version 25.0.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/48 • 24 hours after dose administration (treatment emergent adverse events) The AEs are summarized as treatment emergent adverse events which started within 24 hours after any dose. Subjects are counted once at the highest severity at each organ class and preferred term. The terms were coded using MedDRA, Version 25.0.	2.0% 1/50 • 24 hours after dose administration (treatment emergent adverse events) The AEs are summarized as treatment emergent adverse events which started within 24 hours after any dose. Subjects are counted once at the highest severity at each organ class and preferred term. The terms were coded using MedDRA, Version 25.0.	0.00% 0/51 • 24 hours after dose administration (treatment emergent adverse events) The AEs are summarized as treatment emergent adverse events which started within 24 hours after any dose. Subjects are counted once at the highest severity at each organ class and preferred term. The terms were coded using MedDRA, Version 25.0.
Surgical and medical procedures Fracture treatment	0.00% 0/48 • 24 hours after dose administration (treatment emergent adverse events) The AEs are summarized as treatment emergent adverse events which started within 24 hours after any dose. Subjects are counted once at the highest severity at each organ class and preferred term. The terms were coded using MedDRA, Version 25.0.	2.0% 1/50 • 24 hours after dose administration (treatment emergent adverse events) The AEs are summarized as treatment emergent adverse events which started within 24 hours after any dose. Subjects are counted once at the highest severity at each organ class and preferred term. The terms were coded using MedDRA, Version 25.0.	0.00% 0/51 • 24 hours after dose administration (treatment emergent adverse events) The AEs are summarized as treatment emergent adverse events which started within 24 hours after any dose. Subjects are counted once at the highest severity at each organ class and preferred term. The terms were coded using MedDRA, Version 25.0.

Additional Information

SVP Clinical and Medical Affairs

BioXcel Therapeutics

Phone: (203) 530-5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee "Principal Investigator and Institution may not use it for any publication, presentation, disclosure, or commercial purposes (i.e., furtherance of the interest of any profit-making enterprise). Methods, assessments or procedures used in the collection of the Data, as well as the Study Drug name, Sponsor name and protocol title, are considered confidential and may not be disclosed for scientific, educational or other purposes as specified in paragraph 6."
Publication restrictions are in place

Restriction type: OTHER