NCT05665088

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 13 (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 168 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 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.

Conditions

• Agitation
• Dementia

Interventions

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

Timeline

• Start date: 2022-12-14
• Primary completion: 2023-09-11
• Completion: 2023-09-11
• First posted: 2022-12-27
• Last updated: 2023-12-11

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study