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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT05271552

Public ClinicalTrials.gov record NCT05271552. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 4, 2026, 2:43 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05271552
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
BioXcel Therapeutics Inc
Industry
Enrollment
151 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
65 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 26, 2022
Primary completion
Apr 20, 2023
Completion
Apr 20, 2023
Last update posted
Aug 10, 2026

2022 – 2023

United States locations

U.S. sites
11
U.S. states
6
U.S. cities
11
Facility City State ZIP Site status
BioXcel Clinical Research Site Phoenix Arizona 85016
BioXcel Clinical Research Site Long Beach California 90806
BioXcel Clinical Research Site Daytona Beach Florida 32117
BioXcel Clinical Research Site Lady Lake Florida 32159
BioXcel Clinical Research Site Maitland Florida 32751
BioXcel Clinical Research Site Miami Lakes Florida 33016
BioXcel Clinical Research Site North Miami Florida 33161
BioXcel Clinical Research Site Marrero Louisiana 70072
BioXcel Clinical Research Site Springfield Massachusetts 01103
BioXcel Clinical Research Site Berlin New Jersey 08009
BioXcel Clinical Research Site Toms River New Jersey 08755

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05271552, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 10, 2026 · Synced Sep 4, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05271552 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →