ClinicalTrials.gg
Status unknownNCT03412513Updated Jan 30, 2018

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

A Phase 4 interventional study of Mirabegron and Placebo in Overactive Bladder and Parkinson Disease, sponsored by Seoul National University Hospital. Status unknown at 5 sites in Korea, Republic of. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-01-30.

Sponsored by Seoul National University Hospital · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2018), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Jul 2017, registered Jan 2018).
Phase
Phase 4
Study type
Interventional
Enrollment
144
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 62 studies testing mirabegron in Urinary Bladder, Overactive — 9 open to participants now, 9 under way, 3 of them phase 3. mirabegron · Urinary Bladder, Overactive.

Planned enrollment
38th of 62
144 · median 190
Started
2017
with 3 others
Phase 4
25 of 62
5 open now
Registered
41st of 62
by date
Lead sponsor
3 of 62
Seoul National University Hospital

Among the 62 studies testing mirabegron in Urinary Bladder, Overactive, this one is the 38th largest by planned enrollment, is one of 4 that started in 2017, is one of 25 in phase 4, and was the 41st registered.

Urinary Bladder, Overactive

858 studies on the registry are indexed under Urinary Bladder, Overactive; 126 are open to participants now.

Browse Urinary Bladder, Overactive studies →

Open to participants now

9 of the 62 studies testing mirabegron in Urinary Bladder, Overactive are open now, in 4 countries. Recruiting first, the newest first:

4 more — sign in →

By country, each count listing its studies:

All 9 open studies →

About mirabegron

mirabegron: first FDA approval 2012 (MYRBETRIQ), first EMA approval 2012. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 73 Urinary Bladder, Overactive studies recruiting now, 44 (60%) set no upper age limit and 15 (21%) stop at 75 or younger; 6 take children under 18; 8 take healthy volunteers.

This study: 40 Years to 80 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 62 studies testing mirabegron in Urinary Bladder, Overactive, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Overactive Bladder
  • Parkinson Disease

Keywords

  • Overactive Bladder
  • Parkinson Disease
04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
  • in recent year
  • Screening estimated (eGFR) \< 29, ( aspartate aminotransferase ) or ALT ( alanine aminotransferase ) > 2x , 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
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
144 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • 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

  • DrugPlacebo

    Placebo po daily for 8 weeks to Placebo comparator group.

    Also known as: sugar pill

06

What researchers measure

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

    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 outcomes

  1. 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

    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)

  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

    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)

  3. 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

    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)

  4. 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

    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)

  5. Change in the total score of TSQ (Treatment Satisfaction Questionnaire)

    Change in the total score of TSQ, Visit 3, Visit 4 and Visit 5

    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)

  6. Change in the total score of GRA (Global Response Assessment)

    Change in the total score of GRA, Visit 3, Visit 4 and Visit 5

    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)

  7. Change in the score of BSW (Benefit, Satisfaction and Willingness to Continue Questions)

    Change in the score of BSW, Visit 4 and Visit 5

    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)

  8. Change in the Mean Frequent Urination

    Change in the Mean Frequent Urination, Visit 3 and Visit 4

    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)

  9. Change in the Mean number of Urinary urgency

    Change in the Mean number of Urinary urgency, Visit 3 and Visit 4

    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)

  10. Change in the Mean number of Urinary incontinence

    Change in the Mean number of Urinary incontinence, Visit 3 and Visit 4

    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)

07

Study locations

5 of 5 sites recruiting
  • Kyungpook National University Hospital
    Daegu, Korea, Republic of
    Recruiting
  • Hallym University Medical Center
    Gyeonggi-do, Korea, Republic of
    Recruiting
  • Seoul National University Bundang Hospital
    Gyeonggi-do, Korea, Republic of
    Recruiting
  • Severance Hospital
    Seoul, Korea, Republic of
    Recruiting
  • SMG-SNU Boramae Medical Center
    Seoul, Korea, Republic of
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2017 (actual). Primary completion is estimated for Jul 2018, 11 months after the start.

Of 42 non-industry phase 4 interventional studies under Urinary Bladder, Overactive, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 51. This study's planned 11 months is below that.

Counting every sponsor, half of 54 studies reached it within 23 months; a quarter within 15 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 21, 2018
First posted
Jan 26, 2018
StartActual
Jul 17, 2017
Primary completionEst.
Jul 16, 2018
CompletionEst.
Dec 31, 2018
Last update
Jan 30, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 30, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03412513
Responsible party
Seung-June Oh (Professor, Department of Urology, Seoul National University Hospital) — Principal investigator
First posted
Jan 26, 2018
Start date
Jul 17, 2017
Primary completion
Jul 16, 2018 (estimated)
Completion
Dec 31, 2018 (estimated)
Last update
Jan 30, 2018

Study contacts

Seung-June Oh, MD
Contact
sjo@snu.ac.kr
+82-2-2072-2421
Seung-June Oh, MD
principal investigator · Seoul National University Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Mirabegron

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