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

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 Period In Subjects With Agitation Associated With Dementia

Status Completed

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 28 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. 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. ;

Related Conditions & MeSH terms

• Agitation
• Dementia
• Psychomotor Agitation

• NCT number: NCT05271552
• Study type: Interventional
• Source: BioXcel Therapeutics Inc
• Status: Completed
• Phase: Phase 3
• Start date: April 27, 2022
• Completion date: April 21, 2023