A Pilot Study of Mirabegron and Behavioral Modification Including Pelvic Floor Exercise for Overactive Bladder in Parkinson's Disease (MAESTRO)
NCT02092181 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2021-08-16
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.
Conditions
- Parkinsons Disease
Interventions
- 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.
- DRUG
-
Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
Sponsors & Collaborators
-
Astellas Pharma US, Inc.
collaborator INDUSTRY -
Daniel Burdick, MD
lead INDIV
Principal Investigators
-
Daniel J Burdick, MD · Evergreen Health
-
Pinky Agarwal, MD · Evergreen Health
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 30 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-03-31
- Primary Completion
- 2018-07-01
- Completion
- 2018-07-01
Countries
- United States
Study Locations
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