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

Completed · Phase 4 · Has a placebo group

Conditions studied: Parkinsons Disease

In brief

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.

Key facts

Study ID

NCT02092181

Run by

Daniel Burdick, MD

People needed

30

Starts

2014-03-01

Expected to finish

2018-07-01

Last updated by the study team

2021-08-16

Who can join

Age: 30 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

• Evergreenhealth Booth Gardner Parkinsons Care Center — Kirkland, Washington, United States

Full record on ClinicalTrials.gov

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