A Pilot Study of Mirabegron and Behavioral Modification Including Pelvic Floor Exercise for Overactive Bladder in Parkinson's Disease (MAESTRO)

Parkinsons Disease Clinical Trial

— Maestro  

Official title:

A Pilot Study of Mirabegron and Behavioral Modification Including Pelvic Floor Exercise for Overactive Bladder in Parkinson's Disease. (MAESTRO)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02092181
• Other study ID #: DBPA-2013-01
• Status: Completed
• Phase: Phase 4
• Start date: March 2014
• Est. completion date: July 1, 2018

Study information

• Verified date: July 2021
• Source: Burdick, Daniel, M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 1, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinsons Disease
• Urinary Bladder, Overactive

Intervention

Drug:
• Mirabegron
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.
• Placebo
Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.

Locations

Country	Name	City	State
United States	Evergreenhealth Booth Gardner Parkinsons Care Center	Kirkland	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Daniel Burdick, MD	Astellas Pharma US, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Mean Daily OAB-SCS Visit 3 vs Baseline	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.	baseline (7-14 days post visit 1) and visit 3 (32-40 days post visit 2)
Other	Change in Mean Number of Incontinence Episodes Per 24 Hours	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.	baseline vs visit 3 (32-40 days post baseline) and baseline vs. visit 4 ((74-82 days post visit 2)
Primary	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.	7-82 days. From visit 2 (baseline) to visit 4
Secondary	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.	baseline (7-14 days post visit 1), visit 3( 32-40 days post visit 2) and visit 4(74-82 days post visit 2)
Secondary	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.	baseline (7-14 days post visit 1), visit 3 (32-40 days post visit 2) and visit 4 (74-82 days post visit 2)
Secondary	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	baseline (7-14 days post visit 1), visit 3 (32-40 days post visit 2) and visit 4 (74-82 days post visit 2)
Secondary	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 .	baseline (7-14 days post visit 1), visit 3 (32-40 days post visit 2) and visit 4 (74-82 days post visit 2)