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

NCT02092181 | Completed Phase 4 Results

• 1 other identifier: DBPA-2013-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinsons Disease

Outcome Measures

Primary Outcomes (1)

• Change in the Mean Daily Overactive Bladder-Symptom Composite Score.

  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. Subject ratings ranges from 1 to 6 for each micturition as follows: 1. Not at all, 2.A little bit, 3.Somewhat 4.Quite a bit, 5. A great deal, 6. A very great deal. Maximum score depends on number of micturition episodes in the 72 hour period, as the rating of each episode is summed to get the total score. Higher scores indicate worse symptoms of overactive bladder.

  7-82 days. From visit 2 (baseline) to visit 4

Secondary Outcomes (4)

• Overactive Bladder Questionnaire Symptom Severity Scale( OAB-q)

  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)

  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

  baseline (7-14 days post visit 1), visit 3 (32-40 days post visit 2) and visit 4 (74-82 days post visit 2)

• Subjects Global Impression of Change

  baseline (7-14 days post visit 1), visit 3 (32-40 days post visit 2) and visit 4 (74-82 days post visit 2)

Other Outcomes (2)

• Change in Mean Daily OAB-SCS Visit 3 vs Baseline

  baseline (7-14 days post visit 1) and visit 3 (32-40 days post visit 2)

• Change in Mean Number of Incontinence Episodes Per 24 Hours

  baseline vs visit 3 (32-40 days post baseline) and baseline vs. visit 4 ((74-82 days post visit 2)

Study Arms (2)

Mirabegron

ACTIVE COMPARATOR

1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 mg 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

Placebo

PLACEBO COMPARATOR

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: Placebo

Interventions

Mirabegron DRUG

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.

Also known as: Mirabetriq

Mirabegron

Placebo DRUG

Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.

Also known as: sugar pill

Placebo

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daniel Burdick, MD: lead
• Astellas Pharma US, Inc.: collaborator

Study Sites (1)

Evergreenhealth Booth Gardner Parkinsons Care Center

Kirkland, Washington, 98034, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

mirabegron; Sugars

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates

Results Point of Contact

• Title: Gowri Rajendran
• Organization: Evergreenhealth

grajendran@evergreenhealth.com

425-899-5370

Study Officials

• Daniel J Burdick, MD

  Evergreen Health

  PRINCIPAL INVESTIGATOR

• Pinky Agarwal, MD

  Evergreen Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 7, 2014
• First Posted: March 20, 2014
• Study Start: March 1, 2014
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: August 16, 2021
• Results First Posted: August 16, 2021

Record last verified: 2021-07

Locations

US (1)