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Fesoterodine on Urgency Episodes in Parkinson's Disease Population

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ClinicalTrials.gov Identifier: NCT02385500
Recruitment Status : Terminated (Insufficient or untimely patient recruitment)
First Posted : March 11, 2015
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Lysanne Campeau, MDCM, PhD, FRCSC, Sir Mortimer B. Davis - Jewish General Hospital

Brief 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).


Condition or disease Intervention/treatment Phase
Urinary Bladder, Overactive Parkinson Disease Drug: Fesoterodine Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Randomized Cross-Over Study of Fesoterodine on Urgency Episodes in Parkinson's Disease Population
Actual Study Start Date : September 2016
Actual Primary Completion Date : June 7, 2019
Actual Study Completion Date : June 7, 2019


Arm Intervention/treatment
Placebo Comparator: Placebo
Subjects will be started on placebo tablets, similar to fesoterodine 4 mg, and will have the option to escalate as well.
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.

Other Name: Toviaz

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.

Other Name: Sugar pill

Experimental: Fesoterodine
Drug intervention of fesoterodine 4 mg once a day in the morning after the two-week washout period. They will have the option to escalate to 8 mg (2 tablets of 4 mg each) after 4 weeks on fesoterodine. Patients will have the option to go back to one tablet (i.e., 4 mg) at any time in the study.
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.

Other Name: Toviaz

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.

Other Name: Sugar pill




Primary Outcome Measures :
  1. Urgency episodes [ Time Frame: 10 weeks and 20 weeks ]
    Mean change from baseline in number of urgency episodes per 24 hours


Secondary Outcome Measures :
  1. Micturitions [ Time Frame: 10 weeks and 20 weeks ]
    Mean change from baseline per 24 hours in number of micturitions

  2. Urgency urinary incontinence episodes [ Time Frame: 10 weeks and 20 weeks ]
    Mean change from baseline per 24 hours in number of urgency urinary incontinence episodes

  3. Severe urgency episodes [ Time Frame: 10 weeks and 20 weeks ]
    Mean change from baseline per 24 hours in number of severe urgency episodes

  4. Nocturnal micturitions [ Time Frame: 10 weeks and 20 weeks ]
    Mean change from baseline per 24 hours in number of nocturnal micturitions

  5. Incontinence pads used [ Time Frame: 10 weeks and 20 weeks ]
    Mean change from baseline per 24 hours in number of incontinence pads used

  6. Patient's severity of overactive bladder symptoms as measured by OAB-Q score [ Time Frame: 10 weeks and 20 weeks ]
    Mean change from baseline in OAB-Q score

  7. Patient's perception of his bladder condition as measured by PPBC score [ Time Frame: 10 weeks and 20 weeks ]
    Mean change from baseline in PPBC score

  8. Patient's urgency perception as measured by the UPS score [ Time Frame: 10 weeks and 20 weeks ]
    Mean change from baseline in UPS score

  9. Cognitive ability as measured by the MOCA score [ Time Frame: 10 weeks and 20 weeks ]
    Mean change from baseline in MOCA score

  10. Nocturnal sleep disturbances measured by Parkinson's Disease Sleep Scale [ Time Frame: 10 weeks and 20 weeks ]
    Mean change from baseline in PDSS score (on 120)

  11. Safety of fesoterodine in Parkinson's Disease population [ Time Frame: 10 weeks and 20 weeks ]
    Adverse events or reactions



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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 50-85 years-old
  • self-reported OAB symptoms for ≥3 months
  • a mean of ≥8 micturitions/ 24 hr
  • ≥3 urgency episodes/24 hr on a 3-day bladder diary
  • at least "some moderate problems" on the Patient Perception of Bladder Condition (PPBC)
  • Montreal cognitive assessment (MOCA) score ≥24
  • Stable dose of dopaminergic medications and levodopa (between 300 and 1200 mg daily)

Exclusion Criteria:

  • Urinary retention: PVR >150 ml (as assessed by bladder scan)
  • Contra-indications to fesoterodine
  • Unwilling to stop current antimuscarinics
  • Patients on anticholinergics for motor disturbances
  • Dementia based on clinical evaluation
  • Atypical Parkinsonian syndrome
  • Deep brain stimulation
  • Presence of hallucination

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02385500


Locations
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Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
Sir Mortimer B. Davis - Jewish General Hospital
Investigators
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Principal Investigator: Lysanne Campeau, MD, PhD Sir Mortimer B. Davis - Jewish General Hospital
Publications:

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Responsible Party: Lysanne Campeau, MDCM, PhD, FRCSC, Assistant Professor, Sir Mortimer B. Davis - Jewish General Hospital
ClinicalTrials.gov Identifier: NCT02385500    
Other Study ID Numbers: 15-007
First Posted: March 11, 2015    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Parkinson Disease
Urinary Bladder, Overactive
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Fesoterodine
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents