Trial · NCT02536976
Mirabegron in Parkinson Disease and Impaired Cognition
NCT02536976, Phase 4, Completed, HealthPartners Institute; results first posted 2019-05-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Mirabegron in Parkinson Disease and Impaired Cognition. Trials, record NCT02536976. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02536976
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Mirabegron in Parkinson Disease and Impaired Cognition
- NCT number
- NCT02536976
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 7 participants, actual
- Lead sponsor
- HealthPartners Institute
- Conditions
- Parkinson Disease, Overactive Bladder, Impaired Cognition
- Interventions
- mirabegron, Placebo
- First posted
- 2015-09-01
- Last updated
- 2019-05-08
- Results first posted
- 2019-05-08
- Limitations and caveats
- Study closed before reaching target enrollment. Due to the small number of participants enrolled no statistical analysis was performed, therefore no conclusions can be obtained.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Montreal Cognitive Assessment Total Score | From Week 2 to Week 14 | Change in Montreal Cognitive Assessment Total Score between week 2 and week 14. The Montreal Cognitive Assessment is a screening tool for global cognitive function with a total score ranging from 0 to 30 units on a scale, with higher score indicating better cognitive global function. Normal range is 26 thru 30. |
| Secondary | Change in Overactive Bladder Questionnaire Subscale Scores | From Week 2 to Week 14 | The Overactive Bladder Questionnaire (OABQ) is a 33-item, self-administered instrument that contains a symptom bother scale (8 items) and a health-related quality of life (HRQL) scale (25 items), pertaining to OAB symptoms impact on HRQL. Symptom bother score ranges from 0-100 with higher scores indicating greater severity of symptoms. The HRQL score ranges from 0-100 with higher scores indicating better quality of life. |
| Secondary | Change in Unified Parkinson's Disease Rating Scale | From Week 2 to Week 14 | The UPDRS assesses motor and functional abilities of the subjects as it pertains to Parkinson's disease. The total UPDRS score (range 0-199; defined for this study as the sum of Parts I, II, III, and IV (I-Mentation, behavior, and mood section (4 items; range 0-16); II-Activities of Daily Living (ADL; 13 items; range 0-52); III-motor section (27 items; range 0-108) and IV-complications section; 11 items; range 0-23) will be completed by history and examination. Higher scores indicate greater severity of Parkinson's disease symptoms. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Montreal Cognitive Assessment Total Score | From Week 2 to Week 14 | units on a scale | MEAN | |
| SECONDARY | Change in Overactive Bladder Questionnaire Subscale Scores | From Week 2 to Week 14 | units on a scale | MEAN | |
| SECONDARY | Change in Unified Parkinson's Disease Rating Scale | From Week 2 to Week 14 | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Montreal Cognitive Assessment Total Score | Active Treatment | 1.5 | Full Range -1 to 2 | units on a scale | |
| Change in Montreal Cognitive Assessment Total Score | Placebo | 2 | Full Range 2 to 2 | units on a scale | |
| Change in Overactive Bladder Questionnaire Subscale Scores | Active | Symptom Severity | -13.3 | Full Range -25 to 5 | units on a scale |
| Change in Overactive Bladder Questionnaire Subscale Scores | Placebo | Symptom Severity | 12.5 | Full Range 12.5 to 12.5 | units on a scale |
| Change in Overactive Bladder Questionnaire Subscale Scores | Active | HRQL | 13.7 | Full Range 0 to 25 | units on a scale |
| Change in Overactive Bladder Questionnaire Subscale Scores | Placebo | HRQL | 5 | Full Range 5 to 5 | units on a scale |
| Change in Unified Parkinson's Disease Rating Scale | Active | -5.3 | Full Range -16 to 6 | units on a scale | |
| Change in Unified Parkinson's Disease Rating Scale | Placebo | -9 | Full Range -9 to -9 | units on a scale |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Active Treatment | 3 | |
| Overall Study | STARTED | Placebo | 2 | |
| Overall Study | Randomization | Active Treatment | 3 | |
| Overall Study | Randomization | Placebo | 1 | |
| Overall Study | Dose Escalation and Maintenance | Active Treatment | 3 | |
| Overall Study | Dose Escalation and Maintenance | Placebo | 1 | |
| Overall Study | Washout | Active Treatment | 3 | |
| Overall Study | Washout | Placebo | 1 | |
| Overall Study | COMPLETED | Active Treatment | 3 | |
| Overall Study | COMPLETED | Placebo | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events14
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 | Pneumonia | Respiratory, thoracic and mediastinal disorders | Active Treatment | 0 | 3 | 0 |
| other | Pneumonia | Respiratory, thoracic and mediastinal disorders | Placebo | 1 | 2 | 1 |
| other | hyponatremia | Metabolism and nutrition disorders | Active Treatment | 0 | 3 | 0 |
| other | hyponatremia | Metabolism and nutrition disorders | Placebo | 1 | 2 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Active Treatment | 0 | 3 | 0 |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 1 | 2 | 1 |
| other | constipation | Gastrointestinal disorders | Active Treatment | 0 | 3 | 0 |
| other | constipation | Gastrointestinal disorders | Placebo | 1 | 2 | 1 |
| other | headache | Nervous system disorders | Active Treatment | 0 | 3 | 0 |
| other | headache | Nervous system disorders | Placebo | 1 | 2 | 1 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Active Treatment | 0 | 3 |
| Total, all-cause mortality | Placebo | 0 | 2 |
| Total, other adverse events | Active Treatment | 0 | 3 |
| Total, other adverse events | Placebo | 2 | 2 |
| Total, serious adverse events | Active Treatment | 0 | 3 |
| Total, serious adverse events | Placebo | 0 | 2 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Active Treatment vs Placebo: deaths from any cause | Trial comparisons |
| Active Treatment vs Placebo: serious adverse events | Trial comparisons |
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/NCT02536976
GET https://conductscience.org/api/trials/v1/NCT02536976/registered