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Fesoterodine on Urgency Episodes in Parkinson's Disease Population

NCT02385500 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2019-09-26

No results posted yet for this study

Summary

Parkinson's disease (PD) causes several non-motor autonomic symptoms including lower urinary tract dysfunction. Their symptoms can be managed with antimuscarinics with variable efficacy. Fesoterodine offers a new therapeutic molecule to target the symptoms of urinary frequency, urgency and nocturia in this patient population. The purpose of this protocol is to compare the impact of fesoterodine to placebo on urinary urgency and nocturnal sleep problems in a heterogeneous population of PD patients in a cross-over fashion.

A representative number of patients with baseline overactive bladder (OAB) symptoms and Parkinson's disease will be recruited to receive either the active drug or placebo for the first phase of eight weeks. The groups will then be crossed-over during the second phase of eight weeks. The main outcomes assessed will be the urgency episodes on a 3-day voiding diary, as well as the nocturnal sleep problems will be the Parkinson's Disease Sleep Scale (PDSS).

Conditions

  • Urinary Bladder, Overactive
  • Parkinson Disease

Interventions

DRUG

Fesoterodine

For each phase of the study, the participants will receive a total of 84 pills of fesoterodine 4 mg. The study medication will be provided by Pfizer. For blinded distribution, each bottle of medications will be labeled with a random number for identification. The participant will indicate in a journal the dose taken each day. The study participants will be monitored every 2 weeks with phone calls to assess tolerance or side-effects to the medication.

DRUG

Placebo

For each phase of the study, the participants will receive a total of 84 placebo pills. The study medication will be provided by Pfizer. For blinded distribution, each bottle of medications will be labeled with a random number for identification. The participant will indicate in a journal the dose taken each day. The study participants will be monitored every 2 weeks with phone calls to assess tolerance or side-effects to the medication.

Sponsors & Collaborators

  • Sir Mortimer B. Davis - Jewish General Hospital

    lead OTHER

Principal Investigators

  • Lysanne Campeau, MD, PhD · Sir Mortimer B. Davis - Jewish General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2019-06-07
Completion
2019-06-07

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

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 NCT02385500 on ClinicalTrials.gov