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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: BioXcel Therapeutics Inc · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Agitation
• Dementia

Interventions

Type	Name	Description
DRUG	BXCL501	Sublingual Film
DRUG	Matching Placebo	Sublingual Placebo Film

Timeline

• Start date: 2022-04-27
• Primary completion: 2023-04-21
• Completion: 2023-04-21
• First posted: 2022-03-09
• Last updated: 2025-12-31
• Results posted: 2025-12-31

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study