Clinical trial NCT03412513: Mirabegron for Treatment of Overactive Bladder Symptoms in Patients With Parkinson's Disease
Official title: Mirabegron for Treatment of Overactive Bladder Symptoms in Patients With Parkinson's Disease: a Double-blind, Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Overactive Bladder
Parkinson Disease
Keywords: Overactive Bladder
Parkinson Disease
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-01-26
Enrollment: 144
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in the total score of Overactive Bladder Symptom Scale(OABSS)
timeFrame: 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 outcomes:
measure: Change in the total score of OABSS(Overactive Bladder Symptom Scale)
timeFrame: 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: Change in the total score of IPSS(International Prostate Symptom Score)
timeFrame: 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: Change in the total score of OAB-q short form
timeFrame: 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: Change in the total score of PPBC(Patient Perception of Bladder Condition)
timeFrame: 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: Change in the total score of TSQ (Treatment Satisfaction Questionnaire)
timeFrame: 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: Change in the total score of GRA (Global Response Assessment)
timeFrame: 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: Change in the score of BSW (Benefit, Satisfaction and Willingness to Continue Questions)
timeFrame: 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: Change in the Mean Frequent Urination
timeFrame: 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: Change in the Mean number of Urinary urgency
timeFrame: 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: Change in the Mean number of Urinary incontinence
timeFrame: 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)
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Hallym University Medical Center
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
Study officials:
affiliation: Seoul National University Hospital
name: Seung-June Oh, MD
role: PRINCIPAL_INVESTIGATOR
References: