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

Dementia Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05665088
Study type Interventional
Source BioXcel Therapeutics Inc
Contact
Status Terminated
Phase Phase 3
Start date December 14, 2022
Completion date September 11, 2023
View Details
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