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Pilot Deprescribing of Antimuscarinic Overactive Bladder Medications in Parkinson Disease

NCT07627529 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-06-04

No results posted yet for this study

Summary

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.

Conditions

  • Parkinson Disease (PD)

Interventions

DRUG

Overactive bladder antimuscarinic deprescribing

During the "ON" \[A\] period (up to 10 weeks), the participant will continue taking their overactive bladder antimuscarinic at their maintenance dose. During the "OFF" \[B\] period (i.e., deprescribing), which will last up to 10 weeks, the antimuscarinic dose will be gradually tapered by 25%-50% every 1-2 weeks until the lowest effective dose or complete discontinuation is achieved. Alternative treatment with mirabegron (pharmacologic) may be initiated, as clinically indicated, if the participant experiences intolerable recurrence of overactive bladder symptoms after discontinuation of the antimuscarinic.

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • Corporal Michael J. Crescenz VA Medical Center

    lead FED

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-04-30
Completion
2027-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07627529 on ClinicalTrials.gov