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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03412513
• Date of registration: 21/01/2018
• Prospective Registration: No
• Primary sponsor: Seoul National University Hospital
• Public title: Mirabegron for Treatment of Overactive Bladder Symptoms in Patients With Parkinson's Disease
• Scientific title: Mirabegron for Treatment of Overactive Bladder Symptoms in Patients With Parkinson's Disease: a Double-blind, Randomized Placebo-controlled Trial
• Date of first enrolment: July 17, 2017
• Target sample size: 144
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT03412513
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 4

Countries of recruitment

Korea, Republic of

Contacts

• Name: Seung-June Oh, MD

• Name: Seung-June Oh, MD
• Affiliation: Seoul National University Hospital

Key inclusion & exclusion 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,
?-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



Age minimum: 40 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Overactive Bladder

Parkinson Disease

Intervention(s)

Drug: Placebo

Drug: Mirabegron

Primary Outcome(s)

Change in the total score of Overactive Bladder Symptom Scale(OABSS) [Time Frame: 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(s)

Change in the total score of OABSS(Overactive Bladder Symptom Scale) [Time Frame: 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 [Time Frame: 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 [Time Frame: 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) [Time Frame: 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) [Time Frame: 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) [Time Frame: 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 [Time Frame: 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 [Time Frame: 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) [Time Frame: 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) [Time Frame: 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 ID(s)

PaDOMi Study

Source(s) of Monetary Support

Please refer to primary and secondary sponsors