NCT07627529Not 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
Source: ClinicalTrials.gov · Last updated 4 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 8 May 2026
- Start date
- Jun 2026
- Primary completion date
- Apr 2027
- Lead sponsor
- Corporal Michael J. Crescenz VA Medical Center
- Diseases
- Parkinson disease
- NCT number
- NCT07627529
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 20
- From Jun 2026 to the primary completion date, Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have prior history of hypersensitivity or intolerance to mirabegron or vibegron
Other illness
- Have untreated or uncontrolled hypertension (blood pressure \[BP\] ≥180/110 mmHg),
- Have active urinary tract infection (UTI) or chronic/recurrent UTI (≥2 UTIs in six months or ≥3 in one year)
- Have moderate or severe hepatic impairment (Child-Pugh Score Class B or C)
- Have existing cognitive impairment (Montreal Cognitive Assessment \[MoCA\] score \<22/30) or psychiatric disorder that preclude informed consent
- Have any other condition that, in Principal Investigator (PI) and Co-PI's opinion, makes the individual unsuitable for study participation
Lab values
- 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)
Other
- 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)
Who the study is looking for
- 60+ years old at time of enrollment
- Have a diagnosis of Parkinson disease (PD) made by a movement disorders specialist
- Life expectancy of at least six months
- Are on an antimuscarinic for overactive bladder (OAB) symptoms (without concurrent use of a beta-3 agonist) for at least 3 months
- Are able to provide informed consent
- Are able to complete online surveys/questionnaires
- Are able to receive telephone calls and Zoom calls/telehealth meeting
Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Corporal Michael J. Crescenz VA Medical Center Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.