Back to resultsA Pilot Study of Mirabegron and Behavioral Modification Including Pelvic Floor Exercise for Overactive Bladder in Parkinson's Disease (MAESTRO) (Maestro)
Primary Purpose
Parkinsons Disease
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Mirabegron
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Parkinsons Disease
Eligibility Criteria
Inclusion Criteria:-
- Diagnosis of Parkinsons by United Kingdom brain bank criteria
- Age > 30 years old
- No change in Parkinsons medications during the 4 weeks preceding screening, with no dose changes during the study, except that PRN (as needed) doses of carbidopa/levodopa will be allowed to address periodic worsening of parkinsonian symptoms.
- Patient willing and able to complete micturition diary
- Urinary urgency (≥ 8 entries of bladder urgency score > 2) in 72hr voiding diary during screening period
- Micturition frequency ≥ 8 / 24hr or incontinence ≥ 2 episodes in 72hr voiding diary during screening period
- Use of other medication that could influence bladder function, other than those specifically prohibited (see below), will be permitted as long as the dose is stable for 4 weeks preceding screening, with no dose changes during the study.
- Patient expects to have valid health insurance for the duration of the study period
Exclusion Criteria:
- Women who are breast-feeding, pregnant or have potential to become pregnant during the course of the study (fertile and unwilling/unable to use effective contraceptive measures).
- Cognitive deficits that in the opinion of the investigator would interfere with the subject's ability to give informed consent or perform study testing.
- Screening blood pressure > 165 systolic or 100 diastolic
- Heart rate > 100
- History of allergy to Mirabegron.
- Screening post-void residual > 200ml
- Evidence of urinary tract infection at screening
- History of chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy, or previous or current malignant disease of the pelvic organs
- Intravesical botulinum toxin treatment within the previous six months of screening.
- Presence of Interstim device
- Use of indwelling catheter or self-catheterization
- Concurrent use of thioridazine, flecainide, propafenone, or Digoxin
- Concurrent use of warfarin (Coumadin)
- Use of one of the anti-cholinergic bladder medications specified below within 14 days of the screening visit. Subjects who have used one of these medications in the past but discontinued it at least 14 days prior to the screening visit can be enrolled.
- Screening estimated glomerular filtration rate (eGFR) < 60, AST ( aspartate aminotransferase ) or ALT ( alanine aminotransferase ) > 2x upper limit of normal
- Any other serious and/or unstable medical condition
- Participation in other drug studies or use of other investigational drugs within 30 days prior to Screening Visit.
Sites / Locations
- Evergreenhealth Booth Gardner Parkinsons Care Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Mirabegron
Placebo
Arm Description
1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 mg daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or, for those in the placebo arm, two placebo tablets.
1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets.
Outcomes
Primary Outcome Measures
Change in the Mean Daily Overactive Bladder-Symptom Composite Score.
The primary outcome measure will be the change in the mean daily Overactive Bladder-Symptom Composite Score (OAB-SCS) from baseline (visit 2) to visit 4.
The Over active Bladder- Symptom Composite Score requires subjects to record the severity of urgency of each micturition over a 72 hour period. Subject ratings ranges from 1 to 6 for each micturition as follows: 1. Not at all, 2.A little bit, 3.Somewhat 4.Quite a bit, 5. A great deal, 6. A very great deal. Maximum score depends on number of micturition episodes in the 72 hour period, as the rating of each episode is summed to get the total score. Higher scores indicate worse symptoms of overactive bladder.
Secondary Outcome Measures
Overactive Bladder Questionnaire Symptom Severity Scale( OAB-q)
Overactive Bladder questionnaire symptom severity scale (OAB-q), Visit 3 and Visit 4 vs. baseline Scale ranges from 8 to 48 the higher score indicating worse symptoms.
Non- Motor Symptoms Scale (NMSS)
Non-Motor Symptoms Scale (NMSS), which includes questions about 9 different categories of non-motor symptoms in PD, including urinary symptoms; Visit 3 and Visit 4 vs. baseline.
Symptoms assessed over the last month. The scale ranges from 0 to 360, with higher scores indicating worse symptoms.
Patient Perception of Bladder Condition
Patient Perception of Bladder Condition at Visit 3 and Visit 4 vs. baseline. the scale ranges from 1 to 6 with higher score indicating worse outcome
Subjects Global Impression of Change
Subject's Global Impression of Change at Visit 3 and Visit 4 vs. baseline the scale ranges from 0 to 7 with higher score indicating worse out come .
Full Information
NCT ID
NCT02092181
First Posted
March 7, 2014
Last Updated
July 22, 2021
Sponsor
Daniel Burdick, MD
Collaborators
Astellas Pharma US, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02092181
Brief Title
A Pilot Study of Mirabegron and Behavioral Modification Including Pelvic Floor Exercise for Overactive Bladder in Parkinson's Disease (MAESTRO)
Acronym
Maestro
Official Title
A Pilot Study of Mirabegron and Behavioral Modification Including Pelvic Floor Exercise for Overactive Bladder in Parkinson's Disease. (MAESTRO)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
July 1, 2018 (Actual)
Study Completion Date
July 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Daniel Burdick, MD
Collaborators
Astellas Pharma US, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to see if the study drug, Mirabegron, is safe and effective in treating symptoms of Overactive Bladder in people with Parkinson's Disease.
Detailed Description
This study is a randomized 1:1 placebo-controlled 10-week study of Mirabegron as add-on therapy to an educational intervention of behavioral modification including pelvic floor exercise (PFE) in a cohort of 40 Parkinson's subjects over the age of 30 with overactive bladder (OAB). Active drug will be Mirabegron 25 mg daily with up-titration to 50 mg daily after 5 weeks. Subjects will be enrolled based on response to an overactive bladder questionnaire at visit 2.
Enrolled subjects will have 4 study visits to the clinic as well as 2 phone visits.
Enrolled subjects will be asked to record urinary symptoms and pelvic floor exercises in a diary at 3 separate time points for a 72 hour period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinsons Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mirabegron
Arm Type
Active Comparator
Arm Description
1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 mg daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or, for those in the placebo arm, two placebo tablets.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets.
Intervention Type
Drug
Intervention Name(s)
Mirabegron
Other Intervention Name(s)
Mirabetriq
Intervention Description
25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
sugar pill
Intervention Description
Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
Primary Outcome Measure Information:
Title
Change in the Mean Daily Overactive Bladder-Symptom Composite Score.
Description
The primary outcome measure will be the change in the mean daily Overactive Bladder-Symptom Composite Score (OAB-SCS) from baseline (visit 2) to visit 4.
The Over active Bladder- Symptom Composite Score requires subjects to record the severity of urgency of each micturition over a 72 hour period. Subject ratings ranges from 1 to 6 for each micturition as follows: 1. Not at all, 2.A little bit, 3.Somewhat 4.Quite a bit, 5. A great deal, 6. A very great deal. Maximum score depends on number of micturition episodes in the 72 hour period, as the rating of each episode is summed to get the total score. Higher scores indicate worse symptoms of overactive bladder.
Time Frame
7-82 days. From visit 2 (baseline) to visit 4
Secondary Outcome Measure Information:
Title
Overactive Bladder Questionnaire Symptom Severity Scale( OAB-q)
Description
Overactive Bladder questionnaire symptom severity scale (OAB-q), Visit 3 and Visit 4 vs. baseline Scale ranges from 8 to 48 the higher score indicating worse symptoms.
Time Frame
baseline (7-14 days post visit 1), visit 3( 32-40 days post visit 2) and visit 4(74-82 days post visit 2)
Title
Non- Motor Symptoms Scale (NMSS)
Description
Non-Motor Symptoms Scale (NMSS), which includes questions about 9 different categories of non-motor symptoms in PD, including urinary symptoms; Visit 3 and Visit 4 vs. baseline.
Symptoms assessed over the last month. The scale ranges from 0 to 360, with higher scores indicating worse symptoms.
Time Frame
baseline (7-14 days post visit 1), visit 3 (32-40 days post visit 2) and visit 4 (74-82 days post visit 2)
Title
Patient Perception of Bladder Condition
Description
Patient Perception of Bladder Condition at Visit 3 and Visit 4 vs. baseline. the scale ranges from 1 to 6 with higher score indicating worse outcome
Time Frame
baseline (7-14 days post visit 1), visit 3 (32-40 days post visit 2) and visit 4 (74-82 days post visit 2)
Title
Subjects Global Impression of Change
Description
Subject's Global Impression of Change at Visit 3 and Visit 4 vs. baseline the scale ranges from 0 to 7 with higher score indicating worse out come .
Time Frame
baseline (7-14 days post visit 1), visit 3 (32-40 days post visit 2) and visit 4 (74-82 days post visit 2)
Other Pre-specified Outcome Measures:
Title
Change in Mean Daily OAB-SCS Visit 3 vs Baseline
Description
The primary outcome measure will be the change in the mean daily Overactive Bladder-Symptom Composite Score (OAB-SCS) from baseline (visit 2) to visit 4.
The Over active Bladder- Symptom Composite Score requires subjects to record the severity of urgency of each micturition over a 72 hour period. Subject ratings ranges from 1 to 6 for each micturition as follows: 1. Not at all, 2.A little bit, 3.Somewhat 4.Quite a bit, 5. A great deal, 6. A very great deal. Maximum score depends on number of micturition episodes in the 72 hour period, as the rating of each episode is summed to get the total score. Higher scores indicate worse symptoms of overactive bladder.
Time Frame
baseline (7-14 days post visit 1) and visit 3 (32-40 days post visit 2)
Title
Change in Mean Number of Incontinence Episodes Per 24 Hours
Description
Subjects recorded in a 72-hour micturition diary the number of episodes of urinary incontinence, and this is averaged per 24 hours. Higher scores indicate more episodes of incontinence and thus worse outcome.
Time Frame
baseline vs visit 3 (32-40 days post baseline) and baseline vs. visit 4 ((74-82 days post visit 2)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:-
Diagnosis of Parkinsons by United Kingdom brain bank criteria
Age > 30 years old
No change in Parkinsons medications during the 4 weeks preceding screening, with no dose changes during the study, except that PRN (as needed) doses of carbidopa/levodopa will be allowed to address periodic worsening of parkinsonian symptoms.
Patient willing and able to complete micturition diary
Urinary urgency (≥ 8 entries of bladder urgency score > 2) in 72hr voiding diary during screening period
Micturition frequency ≥ 8 / 24hr or incontinence ≥ 2 episodes in 72hr voiding diary during screening period
Use of other medication that could influence bladder function, other than those specifically prohibited (see below), will be permitted as long as the dose is stable for 4 weeks preceding screening, with no dose changes during the study.
Patient expects to have valid health insurance for the duration of the study period
Exclusion Criteria:
Women who are breast-feeding, pregnant or have potential to become pregnant during the course of the study (fertile and unwilling/unable to use effective contraceptive measures).
Cognitive deficits that in the opinion of the investigator would interfere with the subject's ability to give informed consent or perform study testing.
Screening blood pressure > 165 systolic or 100 diastolic
Heart rate > 100
History of allergy to Mirabegron.
Screening post-void residual > 200ml
Evidence of urinary tract infection at screening
History of chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy, or previous or current malignant disease of the pelvic organs
Intravesical botulinum toxin treatment within the previous six months of screening.
Presence of Interstim device
Use of indwelling catheter or self-catheterization
Concurrent use of thioridazine, flecainide, propafenone, or Digoxin
Concurrent use of warfarin (Coumadin)
Use of one of the anti-cholinergic bladder medications specified below within 14 days of the screening visit. Subjects who have used one of these medications in the past but discontinued it at least 14 days prior to the screening visit can be enrolled.
Screening estimated glomerular filtration rate (eGFR) < 60, AST ( aspartate aminotransferase ) or ALT ( alanine aminotransferase ) > 2x upper limit of normal
Any other serious and/or unstable medical condition
Participation in other drug studies or use of other investigational drugs within 30 days prior to Screening Visit.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel J Burdick, MD
Organizational Affiliation
Evergreen Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pinky Agarwal, MD
Organizational Affiliation
Evergreen Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Evergreenhealth Booth Gardner Parkinsons Care Center
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study of Mirabegron and Behavioral Modification Including Pelvic Floor Exercise for Overactive Bladder in Parkinson's Disease (MAESTRO)
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