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.
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 associated with dementia. 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. Subjects must reside in a care facility where all study-related procedures and study drug dosing will be performed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
13
Sublingual Film
Sublingual Placebo Film
BioXcel Clinical Research Site
Los Alamitos, California, United States
BioXcel Clinical Research Site
Daytona Beach, Florida, United States
BioXcel Clinical Research Site
Maitland, Florida, United States
BioXcel Clinical Research Site
The Villages, Florida, United States
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)
Time frame: 120 minutes post-dose for first episode of agitation
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)
Time frame: 60 minutes post-dose for first episode of agitation
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)
Time frame: 30 minutes post-dose for first episode of agitation
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BioXcel Clinical Research Site
Marrero, Louisiana, United States
BioXcel Clinical Research Site
Springfield, Massachusetts, United States
BioXcel Clinical Research Site
Toms River, New Jersey, United States