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

NCT03412513 | Unknown Phase 4

• 1 other identifier: PaDOMi Study
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 5

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.

Conditions

Overactive Bladder; Parkinson Disease

Keywords

Overactive Bladder; Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Change in the total score of OABSS(Overactive Bladder Symptom Scale)

  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)

  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

  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)

  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)

  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)

Study Arms (2)

Mirabegron

ACTIVE COMPARATOR

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

Drug: Mirabegron

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Mirabegron 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.

Also known as: Betmiga PR 50mg

Mirabegron

Placebo DRUG

Placebo po daily for 8 weeks to Placebo comparator group.

Also known as: sugar pill

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (5)

Kyungpook National University Hospital

Daegu, South Korea

RECRUITING

Hallym University Medical Center

Gyeonggi-do, South Korea

RECRUITING

Seoul National University Bundang Hospital

Gyeonggi-do, South Korea

RECRUITING

Severance Hospital

Seoul, South Korea

RECRUITING

SMG-SNU Boramae Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Urinary Bladder, Overactive; Parkinson Disease

Interventions

mirabegron; Sugars

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

• Seung-June Oh, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seung-June Oh, MD

CONTACT

+82-2-2072-2421; sjo@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Urology

Study Record Dates

• First Submitted: January 21, 2018
• First Posted: January 26, 2018
• Study Start: July 17, 2017
• Primary Completion: July 16, 2018
• Study Completion: December 31, 2018
• Last Updated: January 30, 2018

Record last verified: 2018-01

Locations

KR (5)