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NCT05665088 · ClinicalTrials.gov registry record · Phase 3
Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY III)
A Phase 3 study, sponsored by BioXcel Therapeutics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 13
- Enrollment target
NCT05665088: Clinical Trial Phase 3 study, sponsored by BioXcel Therapeutics.
NCT05665088 is a Phase 3 study that was terminated before completion, run by BioXcel Therapeutics. The registered enrollment target is 13 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05665088, a Phase 3 study, was terminated before completion, sponsored by BioXcel Therapeutics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 13 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 168 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 | 13 participants |
| Start Date | 2022-12-14 |
| Est. Completion | 2023-09-11 |
| Phase | Phase 3 |
Why NCT05665088 stopped before completion
NCT05665088 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Matching Placebo is the first listed.
NCT05665088 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05665088 about?
NCT05665088 is a clinical study titled "Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY III)". 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 168 doses within a 12-week treatment period.
What is the current status of trial NCT05665088?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 13 participants. The study started on 2022-12-14. Estimated completion is 2023-09-11.
What interventions are being tested in trial NCT05665088?
The interventions under investigation include: Matching Placebo (DRUG), BXCL501 (DRUG).
Who is sponsoring clinical trial NCT05665088?
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 NCT05665088's enrollment target sits among peer trials
13 1984th of 2000 higher than 17 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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