- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05271552
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
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85016
- BioXcel Clinical Research Site
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California
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Long Beach, California, United States, 90806
- BioXcel Clinical Research Site
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Florida
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Daytona Beach, Florida, United States, 32117
- BioXcel Clinical Research Site
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Lady Lake, Florida, United States, 32159
- BioXcel Clinical Research Site
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Maitland, Florida, United States, 32751
- BioXcel Clinical Research Site
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Miami Lakes, Florida, United States, 33016
- BioXcel Clinical Research Site
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North Miami, Florida, United States, 33161
- BioXcel Clinical Research Site
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Louisiana
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Marrero, Louisiana, United States, 70072
- BioXcel Clinical Research Site
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Massachusetts
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Springfield, Massachusetts, United States, 01103
- BioXcel Clinical Research Site
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New Jersey
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Berlin, New Jersey, United States, 08009
- BioXcel Clinical Research Site
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Toms River, New Jersey, United States, 08755
- BioXcel Clinical Research Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1- 40 Micrograms
Sublingual film containing 40 Micrograms Dexmedetomidine
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Sublingual Film
Other Names:
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Experimental: Cohort 2- 60 Micrograms
Sublingual film containing 60 Micrograms Dexmedetomidine
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Sublingual Film
Other Names:
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Placebo Comparator: Placebo
Sublingual Placebo film
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Sublingual Placebo Film
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Absolute change from baseline in Positive and Negative Syndrome Scale- Excited Component (PEC) total score
Time Frame: 120 minutes
|
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)
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120 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Absolute change from baseline in Positive and Negative Syndrome Scale- Excited for the first episode of agitation
Time Frame: 60 minutes
|
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)
|
60 minutes
|
Absolute change from baseline in Positive and Negative Syndrome Scale- Excited for the first episode of agitation
Time Frame: 30 minutes
|
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)
|
30 minutes
|
Absolute change from baseline in Positive and Negative Syndrome Scale- Excited for all episodes of agitation
Time Frame: 120 minutes
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Robert Risinger, MD, BioXcel Therapeutics
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Dyskinesias
- Psychomotor Disorders
- Psychomotor Agitation
- Dementia
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Hypnotics and Sedatives
- Dexmedetomidine
Other Study ID Numbers
- BXCL501-303
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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