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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 Oct 20, 2026, 5:36 AM 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 27, 2022 (Actual)
Primary completion
Apr 21, 2023 (Actual)
Completion
Apr 21, 2023 (Actual)
Last update posted
Aug 11, 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 11, 2026 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05271552 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →