NCT05665088|TerminatedPhase 3DMCFDA Drug

Study Stopped

Study was terminated for business reasons; not due to safety or efficacy concerns

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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of PRN Dosing of BXCL501 Over a 12 Week Treatment Period in Subjects With Agitation Associated With Dementia

BioXcel Therapeutics Inc ClinicalTrials.gov

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1 other identifier

BXCL501-304

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredDec 2022

StartedDec 2022

CompletionSep 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 168 doses within a 12-week treatment period.

Trial Health

Monitor

Trial Health Score

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

Enrollment

participants targeted

Target at below P25 for phase_3

Timeline

Completed

Started Dec 2022

Shorter than P25 for phase_3

Geographic Reach

1 country

7 active sites

Status

terminated

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

9 months study duration

Study Start

First participant enrolled

December 14, 2022

Completed

2 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2022

Completed

11 days until next milestone

First Posted

Study publicly available on registry

December 27, 2022

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2023

Completed

Last Updated

December 11, 2023

Status Verified

December 1, 2023

Enrollment Period

9 months

First QC Date

December 16, 2022

Last Update Submit

December 8, 2023

Conditions

Agitation Dementia

Outcome Measures

Primary Outcomes (1)

Change from baseline in Positive and Negative Syndrome Scale- Excited Component (PEC) total score
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 post-dose for first episode of agitation

Secondary Outcomes (2)

Change from baseline in Positive and Negative Syndrome Scale- Excited Component (PEC) total score
60 minutes post-dose for first episode of agitation
Change from baseline in Positive and Negative Syndrome Scale- Excited Component (PEC) total score
30 minutes post-dose for first episode of agitation

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

BXCL501DRUG

Sublingual Film

Also known as: Dexmedetomidine

Cohort 1- 40 MicrogramsCohort 2- 60 Micrograms

Matching PlaceboDRUG

Sublingual Placebo Film

Also known as: Placebo

Placebo

Eligibility Criteria

Age65 Years+

Sexall

Healthy VolunteersNo

Age GroupsOlder Adult (65+)

You may qualify if:

All subjects must have a diagnosis of probable Alzheimer's disease based on NIA-AA criteria (2018). If subject biomarker data are unavailable, per the 2018 NIA-AA diagnostic criteria, the clinical diagnosis of probable AD will be based on the 2011 NIA-AA criteria
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 0 to 20 on the Mini-Mental State Exam (MMSE) and require moderate to full assistance with activities of daily living
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 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.
Subjects with a potential cause for delirium (relatively recent onset agitation and dementia)

Contact the study team to confirm eligibility.