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

NCT ID: NCT03412513

Last Updated: 2018-01-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-17
• Study Completion Date: 2018-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Mirabegron

1:1 randomization to receive Mirabegron 50mg daily or placebo at visit 2. At visit 4 all subjects will receive Mirabegron 50mg.

Group Type: ACTIVE_COMPARATOR

Mirabegron

Intervention Type: 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.

Placebo

1:1 randomization to receive Mirabegron 50mg daily or placebo at visit 2. At visit 4 all subjects will receive Mirabegron 50mg.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo po daily for 8 weeks to Placebo comparator group.

Interventions

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.

Intervention Type: DRUG

Placebo

Placebo po daily for 8 weeks to Placebo comparator group.

Intervention Type: DRUG

Other Intervention Names

Betmiga PR 50mg; sugar pill

Eligibility Criteria

Inclusion Criteria

• Subject who signed a consent form approved from IRB(Institutional Review Board) or IEC(Independent Ethics Committee)
• Diagnosis of Parkinson's disease by a neurologist
• taking a Parkinson's medications stably during 4 weeks preceding screening
• 40 Years to 80 Years, Male and Female
• Patient has overactive bladder symptoms more than 4 weeks preceding screening.
• OABSS questionnaires total score≥ 3 and entries of urinary urgency score≥ 2
• The expanded disability status scale ≤ 7

Exclusion Criteria

• Subjects who have any intervention and operation which can influence on study such as bladder augmentation, vesical sphincter, artificial sphincter, intravesical botulinum toxin treatment etc.
• Use of indwelling catheter or self-catheterization
• acute urinary tract infection or urolithiasis 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
• total volume urine > 3L a day
• Screening post-void residual > 200ml
• Nonpharmacological therapy within the previous 4 weeks of screening
• screening blood pressure >180 systolic or 110 diastolic
• subjects who have orthostatic hypotension, syncope, hypokalemia, or angle-closure glaucoma
• Clinically Significant ECG in recent year
• Screening estimated glomerular filtration rate (eGFR) < 29, AST ( aspartate aminotransferase ) or ALT ( alanine aminotransferase ) > 2x upper limit of normal, γ-GT(gamma-glutamyl transferase) > 3xULN
• take following medication additionally or change the dose: previous 4weeks of screening to end of the study (tamsulosin/silodosin/terazosin, baclofen, diazepam, amitriptyline, DDAVP/desmopressin) previous 12weeks of screening to end of the study (finasteride, dutasteride)
• Use β2- adrenoreceptor agonist, loop diuretic, CYP 3A4 inducer, CYP 2D6 narrow therapeutic index, CYP 3A4 inhibitor, antifungal agent, antiarrhythmic agent
• History of allergy to Mirabegron and beta-adrenergic receptor
• Use of one of the anti-cholinergic bladder medications such as Propiverine / tolterodine / trospium / darifenacin / solifenacin / fesoterodine and mirabegron 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.
• women who have potential to become pregnant during the course of the study

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Seung-June Oh

Professor, Department of Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seung-June Oh, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Kyungpook National University Hospital

Daegu, , South Korea

Site Status: RECRUITING

Hallym University Medical Center

Gyeonggi-do, , South Korea

Site Status: RECRUITING

Seoul National University Bundang Hospital

Gyeonggi-do, , South Korea

Site Status: RECRUITING

Severance Hospital

Seoul, , South Korea

Site Status: RECRUITING

SMG-SNU Boramae Medical Center

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Seung-June Oh, MD

Role: CONTACT

sjo@snu.ac.kr

+82-2-2072-2421

Facility Contacts

Eun Sang Yoo, MD

Role: primary

uroyoo@knu.ac.kr

+82-53-420-5851

Sung Ho Lee, MD

Role: primary

shleeuro@hallym.or.kr

+82-31-8086-2854

Sang Chul Lee, MD

Role: primary

slee@snubh.org

Jang Hwan Kim, MD

Role: primary

jkim@yuhs.ac

Sung Yong Cho, MD

Role: primary

moretry@yahoo.com

+82-2-870-2394

Other Identifiers

PaDOMi Study

Identifier Type: -

Identifier Source: org_study_id