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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mirabegron | Active Comparator | 1:1 randomization to receive Mirabegron 50mg daily or placebo at visit 2. At visit 4 all subjects will receive Mirabegron 50mg. |
|
| Placebo | Placebo Comparator | 1:1 randomization to receive Mirabegron 50mg daily or placebo at visit 2. At visit 4 all subjects will receive Mirabegron 50mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirabegron | Drug | Mirabegron 50mg po daily for 12 weeks to Active Comparator group, and 4 weeks(from visit 4 to visit 5) to Placebo comparator group. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seung-June Oh, MD | Contact | +82-2-2072-2421 | sjo@snu.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Seung-June Oh, MD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyungpook National University Hospital | Recruiting | Daegu | South Korea |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C520025 | mirabegron |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D002241 | Carbohydrates |
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| Placebo | Drug | Placebo po daily for 8 weeks to Placebo comparator group. |
|
|
Change in the total score of IPSS and bothersome score, Visit 3, Visit 4 and Visit 5 |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) |
| Hallym University Medical Center | Recruiting | Gyeonggi-do | South Korea |
|
| Seoul National University Bundang Hospital | Recruiting | Gyeonggi-do | South Korea |
|
| Severance Hospital | Recruiting | Seoul | South Korea |
|
| SMG-SNU Boramae Medical Center | Recruiting | Seoul | South Korea |
|
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |