Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT05271552
PHASE3

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

Sponsor: BioXcel Therapeutics Inc

View on ClinicalTrials.gov

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

DRUG

BXCL501

Sublingual Film

DRUG

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