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Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY II)
Sponsor: BioXcel Therapeutics Inc
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 28 doses within a 12-week treatment period.
Official title: 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
Key Details
Gender
All
Age Range
65 Years - Any
Study Type
INTERVENTIONAL
Enrollment
151
Start Date
2022-04-27
Completion Date
2023-04-21
Last Updated
2026-08-11
Healthy Volunteers
No
Interventions
BXCL501
Sublingual Film
Matching Placebo
Sublingual Placebo Film
Locations (11)
BioXcel Clinical Research Site
Phoenix, Arizona, United States
BioXcel Clinical Research Site
Long Beach, California, United States
BioXcel Clinical Research Site
Daytona Beach, Florida, United States
BioXcel Clinical Research Site
Lady Lake, Florida, United States
BioXcel Clinical Research Site
Maitland, Florida, United States
BioXcel Clinical Research Site
Miami Lakes, Florida, United States
BioXcel Clinical Research Site
North Miami, Florida, United States
BioXcel Clinical Research Site
Marrero, Louisiana, United States
BioXcel Clinical Research Site
Springfield, Massachusetts, United States
BioXcel Clinical Research Site
Berlin, New Jersey, United States
BioXcel Clinical Research Site
Toms River, New Jersey, United States