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Mirabegron in Parkinson Disease and Impaired Cognition | Clinical Trials | Clareo Health

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Mirabegron in Parkinson Disease and Impaired Cognition

A Clinical Trial of Mirabegron for Overactive Bladder Symptoms in Patients With Parkinson Disease and Impaired Cognition

NCT02536976•HealthPartners Institute

View on ClinicalTrials.gov

Summary

There is a high prevalence of OAB symptoms among patients with Parkinson's disease and a lack of pharmacotherapies with an acceptable side effect profile. Specifically, available anticholinergic medications have a high risk of cognitive side-effects, which preclude their use in PD patients with CI. PD can also cause a number of non-motor symptoms that are likely to be adversely affected by the currently available anticholinergic agents. Mirabegron is the first pharmacologic treatment which may not exacerbate CI, constipation, orthostatic hypotension (OH), somnolence, and dry mouth in PD.

Eligibility

Age

25 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Aged 25-80 at screening. Subjects older than 80 will be allowed at the discretion of the PI.
•2. Ambulatory (defined as able to ambulate at least 10 meters, with or without assistance).
•3. Clinical Diagnosis of PD based on the United Kingdom Brain Bank diagnostic criteria for PD.
•4. At baseline visit (Visit 2) patients must have:
•* At least 8 micturitions per 24 hours and
•* At least 3 urgency episodes per 3-day diary.
•5. A MoCA score between 19 and 28 (inclusive) at screening. For those on cognitive enhancers (donepezil, rivastigmine, memantine, galantamine) a MoCA score between 19 and 29 (inclusive) at screening.
•6. Provide informed consent to participate in the study and understand that they may withdraw their consent at any time without prejudice to their future medical care.
•7. Be cognitively capable, in the opinion of investigator, to understand and provide such informed consent.
•8. Be cognitively capable to complete the required questionnaires and assessments, OR have a care partner who is willing and capable to assist them in the completion of these tasks.
+2 more criteria

Exclusion Criteria

•1. Known or suspected alcohol or substance abuse in the preceding 12 months.
•2. Women who are pregnant or breastfeeding.
•3. Women of childbearing potential (WOCP) who are not using at least one method of contraception.
•4. Patients with severe renal impairment (CLcr ≤ 29 mL/min, or eGFR ≤ 29 mL/min/1.73 m2), or moderate or severe hepatic impairment (Child-Pugh classes B or C).
•5. Patients with bladder outlet obstruction (BOO) that, in the opinion of the study urologist, would expose them to risk of urinary retention during treatment with mirabegron.
•6. Patients treated with drugs metabolized by the CYP2D6 pathway.
•7. Patients with supine systolic blood pressure (SBP) ≥ 180 mm Hg, or diastolic blood pressure (DBP) ≥ 110 mm Hg.
•8. Clinically significant, uncontrolled cardiac arrhythmia, unstable angina, congestive heart failure (NYHA Class 3 or 4), or history of myocardial infarction in the preceding 2 years.
•9. History of cancer in the preceding 2 years other than successfully treated, non-metastatic, squamous cell or basal cell carcinoma, or cervical cancer in situ.
•10. Any major urological procedure in the preceding 90 days.
+6 more criteria

Locations (1)

Struthers Parkinson's Center

Golden Valley, Minnesota, United States

Key Dates

Start Date

December 1, 2015

Primary Completion Date

August 1, 2018

Completion Date

August 1, 2018

Last Updated

May 8, 2019

Enrollment

ACTUAL participants

Conditions

Parkinson DiseaseOveractive BladderImpaired Cognition

Interventions

mirabegron

DRUG

Placebo

DRUG

[18F]F-DOPA Imaging in Patients With Autonomic Failure

NCT04246437

Autonomic FailurePure Autonomic Failure+3 more

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RECRUITINGNA

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

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Parkinson Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 8, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Mirabegron in Parkinson Disease and Impaired Cognition

Inclusion Criteria

Exclusion Criteria

[18F]F-DOPA Imaging in Patients With Autonomic Failure

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