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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02092181
• Date of registration: 07/03/2014
• Prospective Registration: No
• Primary sponsor: Daniel Burdick, MD
• Public title: A Pilot Study of Mirabegron and Behavioral Modification Including Pelvic Floor Exercise for Overactive Bladder in Parkinson's Disease (MAESTRO) Maestro
• Scientific title: A Pilot Study of Mirabegron and Behavioral Modification Including Pelvic Floor Exercise for Overactive Bladder in Parkinson's Disease. (MAESTRO)
• Date of first enrolment: March 2014
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02092181
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Pinky Agarwal, MD
• Affiliation: Evergreen Health

• Name: Daniel J Burdick, MD
• Affiliation: Evergreen Health

Key inclusion & exclusion 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.



Age minimum: 30 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinsons Disease

Intervention(s)

Drug: Mirabegron

Drug: Placebo

Primary Outcome(s)

Change in the mean daily Overactive Bladder-Symptom Composite Score. [Time Frame: 7-82 days. From visit 2 (baseline) to visit 4]

Secondary Outcome(s)

Secondary Outcome Measures based on clinic visits [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)]

Secondary Outcome Measures based on clinic visits [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)]

Secondary Outcome Measures based on clinic visits [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)]

Secondary ID(s)

DBPA-2013-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Astellas Pharma US, Inc.