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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03412513
• Other study ID #: PaDOMi Study
• Status: Recruiting
• Phase: Phase 4
• First received: January 21, 2018
• Last updated: January 29, 2018
• Start date: July 17, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2018
• Source: Seoul National University Hospital
• Contact: Seung-June Oh, MD
• Phone: +82-2-2072-2421
• Email: sjo[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: December 31, 2018
• Est. primary completion date: July 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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, ?-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 ß2- 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

Related Conditions & MeSH terms

• Overactive Bladder
• Parkinson Disease
• Urinary Bladder, Overactive

Intervention

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.
• Placebo
Placebo po daily for 8 weeks to Placebo comparator group.

Locations

Country	Name	City	State
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	Hallym University Medical Center	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Gyeonggi-do
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	SMG-SNU Boramae Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)