RightFit
Not yet recruitingPhase 4

Pilot Deprescribing of Antimuscarinic Overactive Bladder Medications in Parkinson Disease

Evaluating the Effect of Deprescribing Antimuscarinic Overactive Bladder Medications on Cognitive Function and Quality of Life of Individuals With Parkinson Disease: A Pharmacist-led Series of N-of-1 Trials

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
60 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 10 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Each period will last up to 10 weeks, allowing for sufficient time for up-titration and onset of drug action, and down-titration and washout."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

This is an unblinded, non-randomized National Institute of Health (NIH) Stage I of Behavioral Intervention Development trial. The investigators will enroll 20 subjects with Parkinson disease (PD) for a series of 20 of N-of-1 trials. The investigators will use a single-arm crossover titration/reversal design ("ON" \[A\] vs. "OFF" \[B\]) with up to 4 periods. All participants will follow the sequence ABAB. Each period will last up to 10 weeks, allowing for sufficient time for up-titration and onset of drug action, and down-titration and washout. Each participant will have the option to participate in less (2-3) or more (3-4) periods depending on whether additional information is needed to make an informed decision about continuing or discontinuing the overactive bladder (OAB) antimuscarinic at the end of the study. The intervention drug will be an OAB antimuscarinic, previously prescribed to the participants by their physician. The investigators will reduce the dose of each OAB antimuscarinic by 25-50% every 1-2 weeks during the "OFF" \[B\] period, with the goal to completely discontinue the medication.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

Inclusion Criteria: 1. 60+ years old at time of enrollment 2. Have a diagnosis of Parkinson disease (PD) made by a movement disorders specialist 3. Life expectancy of at least six months 4. Are on an antimuscarinic for overactive bladder (OAB) symptoms (without concurrent use of a beta-3 agonist) for at least 3 months 5. Are able to provide informed consent 6. Are able to complete online surveys/questionnaires 7. Are able to receive telephone calls and Zoom calls/telehealth meeting Exclusion Criteria: 1. Have untreated or uncontrolled hypertension (blood pressure \[BP\] ≥180/110 mmHg), 2. Have active urinary tract infection (UTI) or chronic/recurrent UTI (≥2 UTIs in six months or ≥3 in one year) 3. Have moderate or severe hepatic impairment (Child-Pugh Score Class B or C) 4. Have severe renal impairment (Estimated Glomerular Filtration Rate \[eGFR\] \<30 mL/min/1.72 m2) or end-stage renal disease (on dialysis or renal replacement therapy) 5. Have prior history of hypersensitivity or intolerance to mirabegron or vibegron 6. Have existing cognitive impairment (Montreal Cognitive Assessment \[MoCA\] score \<22/30) or psychiatric disorder that preclude informed consent 7. Have any other condition that, in Principal Investigator (PI) and Co-PI's opinion, makes the individual unsuitable for study participation 8. On non-oral form of OAB antimuscarinics, the oral solution formulation of oxybutynin chloride or the oral suspension formulation of solifenacin succinate (due to complicated tapering process)

Study sites (1)

PA