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

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.

Study Overview

• Status: Unknown
• Conditions: Overactive Bladder; Parkinson Disease
• Intervention / Treatment: Drug: Mirabegron; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 144
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of
    • Recruiting
    • Kyungpook National University Hospital
    • Contact: Eun Sang Yoo, MD; Phone Number: +82-53-420-5851; Email: uroyoo@knu.ac.kr
  • Gyeonggi-do, Korea, Republic of
    • Recruiting
    • Hallym University Medical Center
    • Contact: Sung Ho Lee, MD; Phone Number: +82-31-8086-2854; Email: shleeuro@hallym.or.kr
  • Gyeonggi-do, Korea, Republic of
    • Recruiting
    • Seoul National University Bundang Hospital
    • Contact: Sang Chul Lee, MD; Email: slee@snubh.org
  • Seoul, Korea, Republic of
    • Recruiting
    • Severance Hospital
    • Contact: Jang Hwan Kim, MD; Email: jkim@yuhs.ac
  • Seoul, Korea, Republic of
    • Recruiting
    • SMG-SNU Boramae Medical Center
    • Contact: Sung Yong Cho, MD; Phone Number: +82-2-870-2394; Email: moretry@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mirabegron; 1:1 randomization to receive Mirabegron 50mg daily or placebo at visit 2. At visit 4 all subjects will receive Mirabegron 50mg.	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.; Other Names: Betmiga PR 50mg
Placebo Comparator: Placebo; 1:1 randomization to receive Mirabegron 50mg daily or placebo at visit 2. At visit 4 all subjects will receive Mirabegron 50mg.	Drug: Placebo; Placebo po daily for 8 weeks to Placebo comparator group.; Other Names: sugar pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)	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)

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Seung-June Oh, MD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2017
• Primary Completion (Anticipated): July 16, 2018
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: January 21, 2018
• First Submitted That Met QC Criteria: January 25, 2018
• First Posted (Actual): January 26, 2018

Study Record Updates

• Last Update Posted (Actual): January 30, 2018
• Last Update Submitted That Met QC Criteria: January 29, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Overactive Bladder; Parkinson Disease
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Urinary Bladder, Overactive; Parkinson Disease; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Adrenergic Agonists; Adrenergic beta-Agonists; Adrenergic beta-3 Receptor Agonists; Mirabegron
• Other Study ID Numbers: PaDOMi Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No