Clinical trial NCT02092181: A Pilot Study of Mirabegron and Behavioral Modification Including Pelvic Floor Exercise for Overactive Bladder in Parkinson's Disease (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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinsons Disease
Lead sponsor: Burdick, Daniel, M.D.
Sponsor class: INDIV
Collaborators: name: Astellas Pharma US, Inc.
First posted: 2014-03-20
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in the Mean Daily Overactive Bladder-Symptom Composite Score.
timeFrame: 7-82 days. From visit 2 (baseline) to visit 4
Secondary outcomes:
measure: Overactive Bladder Questionnaire Symptom Severity Scale( OAB-q)
timeFrame: baseline (7-14 days post visit 1), visit 3( 32-40 days post visit 2) and visit 4(74-82 days post visit 2)
measure: Non- Motor Symptoms Scale (NMSS)
timeFrame: baseline (7-14 days post visit 1), visit 3 (32-40 days post visit 2) and visit 4 (74-82 days post visit 2)
measure: Patient Perception of Bladder Condition
timeFrame: baseline (7-14 days post visit 1), visit 3 (32-40 days post visit 2) and visit 4 (74-82 days post visit 2)
measure: Subjects Global Impression of Change
timeFrame: 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 outcomes:
measure: Change in Mean Daily OAB-SCS Visit 3 vs Baseline
timeFrame: baseline (7-14 days post visit 1) and visit 3 (32-40 days post visit 2)
measure: Change in Mean Number of Incontinence Episodes Per 24 Hours
timeFrame: baseline vs visit 3 (32-40 days post baseline) and baseline vs. visit 4 ((74-82 days post visit 2)
Locations:
city: Kirkland
country: United States
facility: Evergreenhealth Booth Gardner Parkinsons Care Center
state: Washington
Study officials:
affiliation: Evergreen Health
name: Daniel J Burdick, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Evergreen Health
name: Pinky Agarwal, MD
role: PRINCIPAL_INVESTIGATOR
References: