Trial · NCT05271552
Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY II)
NCT05271552, Phase 3, Completed, BioXcel Therapeutics Inc; results first posted 2025-12-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY II). Trials, record NCT05271552. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05271552
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY II)
- NCT number
- NCT05271552
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 151 participants, actual
- Lead sponsor
- BioXcel Therapeutics Inc
- Conditions
- Agitation, Dementia
- Interventions
- BXCL501, Matching Placebo
- First posted
- 2022-03-09
- Last updated
- 2026-08-11
- Results first posted
- 2025-12-31
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score for the First Episode of Agitation | 120 minutes | 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) |
| Secondary | Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited for the First Episode of Agitation | 30 minutes | 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) |
| Secondary | Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited for the First Episode of Agitation | 60 minutes | 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) |
| Secondary | Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited for All Episodes of Agitation | 120 minutes | 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) |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score for the First Episode of Agitation | 120 minutes | Full analysis set included all subjects who took any study medication and who had both baseline and at least one efficacy assessment after dosing. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited for the First Episode of Agitation | 30 minutes | Full Analysis Set (FAS) included all subjects who took any study medication and who had both baseline and at least one efficacy assessment after dosing. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited for the First Episode of Agitation | 60 minutes | Full Analysis Set (FAS) included all subjects who took any study medication and who had both baseline and at least one efficacy assessment after dosing. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited for All Episodes of Agitation | 120 minutes | Full Analysis Set (FAS) included all subjects who took any study medication and who had both baseline and at least one efficacy assessment after dosing. | score on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score for the First Episode of Agitation | Cohort 1- 40 Micrograms | -5.7 | Standard Error 0.6 | score on a scale | |
| Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score for the First Episode of Agitation | Cohort 2- 60 Micrograms | -7.5 | Standard Error 0.6 | score on a scale | |
| Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score for the First Episode of Agitation | Placebo | -5.4 | Standard Error 0.6 | score on a scale | |
| Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited for the First Episode of Agitation | Cohort 1- 40 Micrograms | -2.5 | Standard Error 0.5 | score on a scale | |
| Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited for the First Episode of Agitation | Cohort 2- 60 Micrograms | -3.6 | Standard Error 0.5 | score on a scale | |
| Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited for the First Episode of Agitation | Placebo | -3.4 | Standard Error 0.5 | score on a scale | |
| Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited for the First Episode of Agitation | Cohort 1- 40 Micrograms | -4.2 | Standard Error 0.6 | score on a scale | |
| Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited for the First Episode of Agitation | Cohort 2- 60 Micrograms | -6.2 | Standard Error 0.6 | score on a scale | |
| Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited for the First Episode of Agitation | Placebo | -4.2 | Standard Error 0.6 | score on a scale | |
| Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited for All Episodes of Agitation | Cohort 1- 40 Micrograms | -5.8 | Standard Error 0.5 | score on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1- 40 Micrograms | 48 | |
| Overall Study | STARTED | Cohort 2- 60 Micrograms | 50 | |
| Overall Study | STARTED | Placebo | 53 | |
| Overall Study | COMPLETED | Cohort 1- 40 Micrograms | 38 | |
| Overall Study | COMPLETED | Cohort 2- 60 Micrograms | 29 | |
| Overall Study | COMPLETED | Placebo | 32 | |
| Overall Study | NOT COMPLETED | Cohort 1- 40 Micrograms | 10 | |
| Overall Study | NOT COMPLETED | Cohort 2- 60 Micrograms | 21 | |
| Overall Study | NOT COMPLETED | Placebo | 21 |
Source ClinicalTrials.gov
Adverse events33
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Somnolence | Nervous system disorders | Cohort 1- 40 Micrograms | 2 | 48 | |
| other | Somnolence | Nervous system disorders | Cohort 2- 60 Micrograms | 3 | 50 | |
| other | Somnolence | Nervous system disorders | Placebo | 0 | 51 | |
| other | Hypotension | Vascular disorders | Cohort 1- 40 Micrograms | 0 | 48 | |
| other | Hypotension | Vascular disorders | Cohort 2- 60 Micrograms | 3 | 50 | |
| other | Hypotension | Vascular disorders | Placebo | 0 | 51 | |
| other | Orthostatic Hypotension | Vascular disorders | Cohort 1- 40 Micrograms | 2 | 48 | |
| other | Orthostatic Hypotension | Vascular disorders | Cohort 2- 60 Micrograms | 2 | 50 | |
| other | Orthostatic Hypotension | Vascular disorders | Placebo | 0 | 51 | |
| other | Bradycardia | Cardiac disorders | Cohort 1- 40 Micrograms | 1 | 48 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1- 40 Micrograms | 1 | 48 |
| Total, all-cause mortality | Cohort 2- 60 Micrograms | 1 | 50 |
| Total, all-cause mortality | Placebo | 1 | 51 |
| Total, other adverse events | Cohort 1- 40 Micrograms | 6 | 48 |
| Total, other adverse events | Cohort 2- 60 Micrograms | 16 | 50 |
| Total, other adverse events | Placebo | 2 | 51 |
| Total, serious adverse events | Cohort 1- 40 Micrograms | 0 | 48 |
| Total, serious adverse events | Cohort 2- 60 Micrograms | 0 | 50 |
| Total, serious adverse events | Placebo | 0 | 51 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05271552
GET https://conductscience.org/api/trials/v1/NCT05271552/events?page=2