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NCT05271552 · ClinicalTrials.gov registry record · Phase 3
Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY II)
A Phase 3 study, sponsored by BioXcel Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 151
- Enrollment target
NCT05271552: Completed Phase 3 study, sponsored by BioXcel Therapeutics.
NCT05271552 is a Phase 3 study that has completed, run by BioXcel Therapeutics. The registered enrollment target is 151 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05271552, a Phase 3 study, has completed, sponsored by BioXcel Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 151 participants
- Enrollment target
Study 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.
Primary Outcome
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)
Interventions
- DRUG Matching Placebo
- DRUG BXCL501
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 151 participants |
| Start Date | 2022-04-27 |
| Est. Completion | 2023-04-21 |
| Phase | Phase 3 |
What the finished NCT05271552 record still lists
NCT05271552 is an interventional study that assigns participants to a tested intervention. The registered 151 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Matching Placebo is the first listed.
NCT05271552 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05271552 about?
NCT05271552 is a clinical study titled "Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY II)". 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.
What is the current status of trial NCT05271552?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 151 participants. The study started on 2022-04-27. Estimated completion is 2023-04-21.
What interventions are being tested in trial NCT05271552?
The interventions under investigation include: Matching Placebo (DRUG), BXCL501 (DRUG).
Who is sponsoring clinical trial NCT05271552?
This trial is sponsored by BioXcel Therapeutics, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05271552's enrollment target sits among peer trials
151 1517th of 2000 higher than 482 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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