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

NCT ID: NCT05271552

Last Updated: 2025-12-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-27

Study Completion Date

2023-04-21

Brief Summary

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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

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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.

Conditions

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Agitation Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Double-Blinded

Study Groups

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Cohort 1- 40 Micrograms

Sublingual film containing 40 Micrograms Dexmedetomidine

Group Type EXPERIMENTAL

BXCL501

Intervention Type DRUG

Sublingual Film

Cohort 2- 60 Micrograms

Sublingual film containing 60 Micrograms Dexmedetomidine

Group Type EXPERIMENTAL

BXCL501

Intervention Type DRUG

Sublingual Film

Placebo

Sublingual Placebo film

Group Type PLACEBO_COMPARATOR

Matching Placebo

Intervention Type DRUG

Sublingual Placebo Film

Interventions

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BXCL501

Sublingual Film

Intervention Type DRUG

Matching Placebo

Sublingual Placebo Film

Intervention Type DRUG

Other Intervention Names

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Dexmedetomidine Placebo

Eligibility Criteria

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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

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)
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cognitive Research Corporation

INDUSTRY

Sponsor Role collaborator

BioXcel Therapeutics Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Risinger, MD

Role: STUDY_CHAIR

BioXcel Therapeutics

Locations

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BioXcel Clinical Research Site

Phoenix, Arizona, United States

Site Status

BioXcel Clinical Research Site

Long Beach, California, United States

Site Status

BioXcel Clinical Research Site

Daytona Beach, Florida, United States

Site Status

BioXcel Clinical Research Site

Lady Lake, Florida, United States

Site Status

BioXcel Clinical Research Site

Maitland, Florida, United States

Site Status

BioXcel Clinical Research Site

Miami Lakes, Florida, United States

Site Status

BioXcel Clinical Research Site

North Miami, Florida, United States

Site Status

BioXcel Clinical Research Site

Marrero, Louisiana, United States

Site Status

BioXcel Clinical Research Site

Springfield, Massachusetts, United States

Site Status

BioXcel Clinical Research Site

Berlin, New Jersey, United States

Site Status

BioXcel Clinical Research Site

Toms River, New Jersey, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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BXCL501-303

Identifier Type: -

Identifier Source: org_study_id