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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
144
Mirabegron 50mg po daily for 12 weeks to Active Comparator group, and 4 weeks(from visit 4 to visit 5) to Placebo comparator group.
Placebo po daily for 8 weeks to Placebo comparator group.
Kyungpook National University Hospital
Daegu, South Korea
RECRUITINGHallym University Medical Center
Gyeonggi-do, South Korea
RECRUITINGSeoul National University Bundang Hospital
Gyeonggi-do, South Korea
Change in the total score of Overactive Bladder Symptom Scale(OABSS)
Change in the total score of Overactive Bladder Symptom Scale(OABSS) from baseline(Visit 2) to Visit 4
Time frame: Baseline(Visit 2 : 0 week), Visit 3(3-5 weeks post Visit 2), Visit 4(6-10 weeks post Visit 2), Visit 5(10-14 weeks post Visit 2)
Change in the total score of OABSS(Overactive Bladder Symptom Scale)
Change in the total score of OABSS, Visit 3, Visit 4 and Visit 5
Time frame: Baseline(Visit 2 : 0 week), Visit 3(3-5 weeks post Visit 2), Visit 4(6-10 weeks post Visit 2), Visit 5(10-14 weeks post Visit 2)
Change in the total score of IPSS(International Prostate Symptom Score)
Change in the total score of IPSS and bothersome score, Visit 3, Visit 4 and Visit 5
Time frame: Baseline(Visit 2 : 0 week), Visit 3(3-5 weeks post Visit 2), Visit 4(6-10 weeks post Visit 2), Visit 5(10-14 weeks post Visit 2)
Change in the total score of OAB-q short form
Change in the total score of OAB-q short form,Visit 3, Visit 4 and Visit 5
Time frame: Baseline(Visit 2 : 0 week), Visit 3(3-5 weeks post Visit 2), Visit 4(6-10 weeks post Visit 2), Visit 5(10-14 weeks post Visit 2)
Change in the total score of PPBC(Patient Perception of Bladder Condition)
Change in the total score of PPBC, Visit 3, Visit 4 and Visit 5
Time frame: Baseline(Visit 2 : 0 week), Visit 3(3-5 weeks post Visit 2), Visit 4(6-10 weeks post Visit 2), Visit 5(10-14 weeks post Visit 2)
Change in the total score of TSQ (Treatment Satisfaction Questionnaire)
Change in the total score of TSQ, Visit 3, Visit 4 and Visit 5
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Severance Hospital
Seoul, South Korea
RECRUITINGSMG-SNU Boramae Medical Center
Seoul, South Korea
RECRUITINGTime frame: Baseline(Visit 2 : 0 week), Visit 3(3-5 weeks post Visit 2), Visit 4(6-10 weeks post Visit 2), Visit 5(10-14 weeks post Visit 2)
Change in the total score of GRA (Global Response Assessment)
Change in the total score of GRA, Visit 3, Visit 4 and Visit 5
Time frame: Baseline(Visit 2 : 0 week), Visit 3(3-5 weeks post Visit 2), Visit 4(6-10 weeks post Visit 2), Visit 5(10-14 weeks post Visit 2)
Change in the score of BSW (Benefit, Satisfaction and Willingness to Continue Questions)
Change in the score of BSW, Visit 4 and Visit 5
Time frame: Baseline(Visit 2 : 0 week), Visit 3(3-5 weeks post Visit 2), Visit 4(6-10 weeks post Visit 2), Visit 5(10-14 weeks post Visit 2)
Change in the Mean Frequent Urination
Change in the Mean Frequent Urination, Visit 3 and Visit 4
Time frame: Baseline(Visit 2 : 0 week), Visit 3(3-5 weeks post Visit 2), Visit 4(6-10 weeks post Visit 2), Visit 5(10-14 weeks post Visit 2)
Change in the Mean number of Urinary urgency
Change in the Mean number of Urinary urgency, Visit 3 and Visit 4
Time frame: Baseline(Visit 2 : 0 week), Visit 3(3-5 weeks post Visit 2), Visit 4(6-10 weeks post Visit 2), Visit 5(10-14 weeks post Visit 2)
Change in the Mean number of Urinary incontinence
Change in the Mean number of Urinary incontinence, Visit 3 and Visit 4
Time frame: Baseline(Visit 2 : 0 week), Visit 3(3-5 weeks post Visit 2), Visit 4(6-10 weeks post Visit 2), Visit 5(10-14 weeks post Visit 2)