NCT05271552Phase 3Completed

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

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

Open ClinicalTrials.gov record CSV export · Pro

Primary completion2023-04-21Actual

Enrollment · participants151Actual

Source updated2026-08-11Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

Pro unlocks the full available history and CSV export. View Pro features

Posted 2025-12-31 · 1 field changed

Main study measure wording changed

Text changed; whether the study measures changed has not been verified. Saved text may be shortened.

Compare wording

− Before

Measure: Absolute ~~change~~ ~~from~~ ~~baseline~~ in Positive and Negative Syndrome Scale- Excited Component (PEC) ~~total~~ ~~score~~

+ After

Measure: Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score for the First Episode of Agitation

Check registry source

Study details

Conditions studied

Agitation; Dementia

Treatments or interventions studied

BXCL501DrugAlso known as Dexmedetomidine
Matching PlaceboDrugAlso known as Placebo

Primary outcomes · main study measures

Read the study measures

measure: Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score for the First Episode of Agitation; description: The Positive and Negative Syndrome Scale - Excited Component (PEC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The PEC, the sum of these 5 subscales, thus ranges from 5 (absence of agitation) to 35 (extremely severe); timeFrame: 120 minutes

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

How to read this history