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Mirabegron in Parkinson Disease and Impaired Cognition (MICT-PD)

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ClinicalTrials.gov Identifier: NCT02536976
Recruitment Status : Completed
First Posted : September 1, 2015
Results First Posted : May 8, 2019
Last Update Posted : May 8, 2019
Sponsor:
Information provided by (Responsible Party):
HealthPartners Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Overactive Bladder Impaired Cognition Drug: mirabegron Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Clinical Trial of Mirabegron for Overactive Bladder Symptoms in Patients With Parkinson Disease and Impaired Cognition
Study Start Date : December 2015
Actual Primary Completion Date : August 1, 2018
Actual Study Completion Date : August 1, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Mirabegron

Arm Intervention/treatment
Experimental: Active treatment
mirabegron
Drug: mirabegron
Other Name: Myrbetriq

Placebo Comparator: Placebo
Matching placebo
Drug: Placebo



Primary Outcome Measures :
  1. Change in Montreal Cognitive Assessment Total Score [ Time Frame: 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 Outcome Measures :
  1. Change in Overactive Bladder Questionnaire Subscale Scores [ Time Frame: 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.

  2. Change in Unified Parkinson's Disease Rating Scale [ Time Frame: 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.



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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  9. Be on a stable regimen of antiparkinson's medications at least 30 days prior to screening, and be expected to remain on a stable dose for the duration of the study.
  10. If taking cognitive enhancers (donepezil, rivastigmine, memantine, galantamine), must be on stable dose at least 30 days prior to screening, and be expected to remain on a stable dose for the duration of the study.

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.
  11. Any major surgical procedure in the preceding 30 days.
  12. Previously treated with mirabegron within 60 days prior to the baseline visit (Visit 2), or previously having failed treatment with mirabegron regardless of duration and timing of treatment.
  13. Current or previous, within the 60 days preceding the baseline visit (Visit 2), treatment with antimuscarinic agents for OAB symptoms; and, willingness to not use antimuscarinic agents for the duration of the study.
  14. Currently receiving any other investigational drug or having received an investigational drug within the 60 days preceding the baseline visit (Visit 2).
  15. Any condition or laboratory test result, which, in the opinion of the Investigator or the Study Urologist, might result in an increased risk to the patient, or would affect their participation in the study.
  16. Any patient who, in the opinion of the Investigator, is not a good candidate for the study or will not be able to follow study procedures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536976


Locations
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United States, Minnesota
Struthers Parkinson's Center
Golden Valley, Minnesota, United States, 55427
Sponsors and Collaborators
HealthPartners Institute
Investigators
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Principal Investigator: Sotirios A Parashos, MD, PhD Struthers Parkinson's Center
  Study Documents (Full-Text)

Documents provided by HealthPartners Institute:

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Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT02536976     History of Changes
Other Study ID Numbers: 04412-15-A
First Posted: September 1, 2015    Key Record Dates
Results First Posted: May 8, 2019
Last Update Posted: May 8, 2019
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by HealthPartners Institute:
mirabegron
Additional relevant MeSH terms:
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Parkinson Disease
Urinary Bladder, Overactive
Cognitive Dysfunction
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Mirabegron
Adrenergic beta-3 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents