NCT03412513

Mirabegron for Treatment of Overactive Bladder Symptoms in Patients With Parkinson's Disease

Mirabegron for Treatment of Overactive Bladder Symptoms in Patients With Parkinson's Disease: a Double-blind, Randomized Placebo-controlled Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see the study drug, Mirabegron, is safe and effective in treating symptoms of Overactive Bladder in patients with Parkinson's disease.

Detailed description

This study is a randomized 1:1 placebo-controlled 12-week study of Mirabegron in 144 Parkinson's subjects the age of 40 to 80 with overactive bladder. Active drug will be Mirabegron 50mg daily. Subjects will be enrolled based on response to an overactive bladder questionnaire at visit 1. Enrolled subjects will have 3 study visits to the clinic as well as 1 phone visit.

Conditions

• Overactive Bladder
• Parkinson Disease

Interventions

Type	Name	Description
DRUG	Mirabegron	Mirabegron 50mg po daily for 12 weeks to Active Comparator group, and 4 weeks(from visit 4 to visit 5) to Placebo comparator group.
DRUG	Placebo	Placebo po daily for 8 weeks to Placebo comparator group.

Timeline

• Start date: 2017-07-17
• Primary completion: 2018-07-16
• Completion: 2018-12-31
• First posted: 2018-01-26
• Last updated: 2018-01-30

Locations

5 sites across 1 country: South Korea