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A Pilot Study of Mirabegron and Behavioral Modification Including Pelvic Floor Exercise for Overactive Bladder in Parkinson's Disease (MAESTRO) (Maestro)

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ClinicalTrials.gov Identifier: NCT02092181
Recruitment Status : Completed
First Posted : March 20, 2014
Last Update Posted : July 10, 2018
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
Daniel Burdick, MD, Burdick, Daniel, M.D.

Brief Summary:
The purpose of this study is to see if the study drug, Mirabegron, is safe and effective in treating symptoms of Overactive Bladder in people with Parkinson's Disease.

Condition or disease Intervention/treatment Phase
Parkinsons Disease Drug: Mirabegron Drug: Placebo Phase 4

Detailed Description:

This study is a randomized 1:1 placebo-controlled 10-week study of Mirabegron as add-on therapy to an educational intervention of behavioral modification including pelvic floor exercise (PFE) in a cohort of 40 Parkinson's subjects over the age of 30 with overactive bladder (OAB). Active drug will be Mirabegron 25 mg daily with up-titration to 50 mg daily after 5 weeks. Subjects will be enrolled based on response to an overactive bladder questionnaire at visit 2.

Enrolled subjects will have 4 study visits to the clinic as well as 2 phone visits.

Enrolled subjects will be asked to record urinary symptoms and pelvic floor exercises in a diary at 3 separate time points for a 72 hour period.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Study of Mirabegron and Behavioral Modification Including Pelvic Floor Exercise for Overactive Bladder in Parkinson's Disease. (MAESTRO)
Study Start Date : March 2014
Actual Primary Completion Date : July 1, 2018
Actual Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Mirabegron

Arm Intervention/treatment
Active Comparator: Mirabegron
1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets.
Drug: Mirabegron
25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
Other Name: Mirabetriq

Drug: Placebo
Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
Other Name: sugar pill

Placebo Comparator: Placebo
1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets.
Drug: Mirabegron
25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
Other Name: Mirabetriq

Drug: Placebo
Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
Other Name: sugar pill




Primary Outcome Measures :
  1. Change in the mean daily Overactive Bladder-Symptom Composite Score. [ Time Frame: 7-82 days. From visit 2 (baseline) to visit 4 ]

    The primary outcome measure will be the change in the mean daily Overactive Bladder-Symptom Composite Score (OAB-SCS) from baseline (visit 2) to visit 4.

    The Over active Bladder- Symptom Composite Score requires subjects to record the severity of urgency of each micturition over a 72 hour period.



Secondary Outcome Measures :
  1. Secondary Outcome Measures based on clinic visits [ Time Frame: baseline (7-14 days post visit 1), visit 3( 32-40 days post visit 2) and visit 4(74-82 days post visit 2) ]
    Overactive Bladder questionnaire symptom severity scale (OAB-q), Visit 3 and Visit 4 vs. baseline

  2. Secondary Outcome Measures based on clinic visits [ Time Frame: baseline (7-14 days post visit 1), visit 3 (32-40 days post visit 2) and visit 4 (74-82 days post visit 2) ]
    Non-Motor Symptoms Scale (NMSS), which includes questions about cognition, psychosis, and constipation, in addition to urinary symptoms; Visit 3 and Visit 4 vs. baseline.

  3. Secondary Outcome Measures based on clinic visits [ Time Frame: baseline ( 7-14 days post visit 1), visit 3 (32-40 days post visit 2) and visit 4 (74-82 days post visit 2) ]
    PDQ-8, a measure of global quality of life, Visit 3 and Visit 4 vs. baseline

  4. Secondary Outcome Measures based on clinic visits [ Time Frame: baseline (7-14 days post visit 1), visit 3 (32-40 days post visit 2) and visit 4 (74-82 days post visit 2) ]
    Patient Perception of Bladder Condition at Visit 3 and Visit 4 vs. baseline

  5. Secondary Outcome Measures based on clinic visits [ Time Frame: baseline (7-14 days post visit 1), visit 3 (32-40 days post visit 2) and visit 4 (74-82 days post visit 2) ]
    Subject's Global Impression of Change at Visit 3 and Visit 4 vs. baseline


Other Outcome Measures:
  1. Secondary Outcome Measures based on Voiding Diary [ Time Frame: baseline (7-14 days post visit 1) and visit 3 (32-40 days post visit 2) ]
    Change in mean daily OAB-SCS, Visit 3 vs. baseline

  2. Secondary Outcome Measures based on Voiding Diary [ Time Frame: baseline (7-14 days post visit 1), visit 3 (32-40 days post visit 2) and visit 4 (74-82 days post visit 2) ]
    Mean number of micturitions per 24 hours, Visit 3 and Visit 4 vs. baseline

  3. Secondary Outcome Measures based on Voiding Diary [ Time Frame: baseline (7-14 days post visit 1) visit 3 (32-40 days post visit 2) and visit 4 (74-82 days post visit 2) ]
    Mean number of incontinence episodes per 24 hours, Visit 3 and Visit 4 vs. baseline

  4. Secondary Outcome Measures based on Voiding Diary [ Time Frame: baseline (7-14 dayspost visit 1) visit 3 (32-40 days post visit 2) and visit 4 (74-82 days post visit 2) ]
    Mean Volume voided per micturition



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:-

  • Diagnosis of Parkinsons by United Kingdom brain bank criteria
  • Age > 30 years old
  • No change in Parkinsons medications during the 4 weeks preceding screening, with no dose changes during the study, except that PRN (as needed) doses of carbidopa/levodopa will be allowed to address periodic worsening of parkinsonian symptoms.
  • Patient willing and able to complete micturition diary
  • Urinary urgency (≥ 8 entries of bladder urgency score > 2) in 72hr voiding diary during screening period
  • Micturition frequency ≥ 8 / 24hr or incontinence ≥ 2 episodes in 72hr voiding diary during screening period
  • Use of other medication that could influence bladder function, other than those specifically prohibited (see below), will be permitted as long as the dose is stable for 4 weeks preceding screening, with no dose changes during the study.
  • Patient expects to have valid health insurance for the duration of the study period

Exclusion Criteria:

  • Women who are breast-feeding, pregnant or have potential to become pregnant during the course of the study (fertile and unwilling/unable to use effective contraceptive measures).
  • Cognitive deficits that in the opinion of the investigator would interfere with the subject's ability to give informed consent or perform study testing.
  • Screening blood pressure > 165 systolic or 100 diastolic
  • Heart rate > 100
  • History of allergy to Mirabegron.
  • Screening post-void residual > 200ml
  • Evidence of urinary tract infection 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
  • Intravesical botulinum toxin treatment within the previous six months of screening.
  • Presence of Interstim device
  • Use of indwelling catheter or self-catheterization
  • Concurrent use of thioridazine, flecainide, propafenone, or Digoxin
  • Concurrent use of warfarin (Coumadin)
  • Use of one of the anti-cholinergic bladder medications specified below 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.
  • Screening estimated glomerular filtration rate (eGFR) < 60, AST ( aspartate aminotransferase ) or ALT ( alanine aminotransferase ) > 2x upper limit of normal
  • Any other serious and/or unstable medical condition
  • Participation in other drug studies or use of other investigational drugs within 30 days prior to Screening Visit.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02092181


Locations
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United States, Washington
Evergreenhealth Booth Gardner Parkinsons Care Center
Kirkland, Washington, United States, 98034
Sponsors and Collaborators
Daniel Burdick, MD
Astellas Pharma US, Inc.
Investigators
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Principal Investigator: Daniel J Burdick, MD Evergreen Health
Principal Investigator: Pinky Agarwal, MD Evergreen Health

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Responsible Party: Daniel Burdick, MD, Principal Investigator, Burdick, Daniel, M.D.
ClinicalTrials.gov Identifier: NCT02092181     History of Changes
Other Study ID Numbers: DBPA-2013-01
First Posted: March 20, 2014    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2017

Additional relevant MeSH terms:
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Parkinson Disease
Urinary Bladder, Overactive
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Mirabegron
Adrenergic beta-3 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents