Fesoterodine on Urgency Episodes in Parkinson's Disease Population

NCT02385500 | Terminated Phase 4 DMC

• 1 other identifier: 15-007
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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).

Conditions

Urinary Bladder, Overactive; Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Urgency episodes

  Mean change from baseline in number of urgency episodes per 24 hours

  10 weeks and 20 weeks

Secondary Outcomes (11)

• Micturitions

  10 weeks and 20 weeks

• Urgency urinary incontinence episodes

  10 weeks and 20 weeks

• Severe urgency episodes

  10 weeks and 20 weeks

• Nocturnal micturitions

  10 weeks and 20 weeks

• Incontinence pads used

  10 weeks and 20 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Subjects will be started on placebo tablets, similar to fesoterodine 4 mg, and will have the option to escalate as well.

Drug: Fesoterodine; Drug: Placebo

Fesoterodine

EXPERIMENTAL

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; Drug: Placebo

Interventions

Fesoterodine DRUG

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.

Also known as: Toviaz

Fesoterodine; Placebo

Placebo DRUG

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.

Also known as: Sugar pill

Fesoterodine; Placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sir Mortimer B. Davis - Jewish General Hospital: lead

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Related Publications (14)

• Winge K, Skau AM, Stimpel H, Nielsen KK, Werdelin L. Prevalence of bladder dysfunction in Parkinsons disease. Neurourol Urodyn. 2006;25(2):116-22. doi: 10.1002/nau.20193.

  PMID: 16402391 BACKGROUND

• Campeau L, Soler R, Andersson KE. Bladder dysfunction and parkinsonism: current pathophysiological understanding and management strategies. Curr Urol Rep. 2011 Dec;12(6):396-403. doi: 10.1007/s11934-011-0219-8.

  PMID: 21986769 BACKGROUND

• Katzenschlager R, Sampaio C, Costa J, Lees A. Anticholinergics for symptomatic management of Parkinson's disease. Cochrane Database Syst Rev. 2003;2002(2):CD003735. doi: 10.1002/14651858.CD003735.

  PMID: 12804486 BACKGROUND

• Donnellan CA, Fook L, McDonald P, Playfer JR. Oxybutynin and cognitive dysfunction. BMJ. 1997 Nov 22;315(7119):1363-4. doi: 10.1136/bmj.315.7119.1363. No abstract available.

  PMID: 9402781 BACKGROUND

• Hoyles K, Sharma JC. Olfactory loss as a supporting feature in the diagnosis of Parkinson's disease: a pragmatic approach. J Neurol. 2013 Dec;260(12):2951-8. doi: 10.1007/s00415-013-6848-8. Epub 2013 Feb 3.

  PMID: 23377435 BACKGROUND

• Wagg A, Dale M, Tretter R, Stow B, Compion G. Randomised, multicentre, placebo-controlled, double-blind crossover study investigating the effect of solifenacin and oxybutynin in elderly people with mild cognitive impairment: the SENIOR study. Eur Urol. 2013 Jul;64(1):74-81. doi: 10.1016/j.eururo.2013.01.002. Epub 2013 Jan 11.

  PMID: 23332882 BACKGROUND

• Abrams P, Cardozo L, Chapple C, Serdarevic D, Hargreaves K, Khullar V; 1032 Study Group. Comparison of the efficacy, safety, and tolerability of propiverine and oxybutynin for the treatment of overactive bladder syndrome. Int J Urol. 2006 Jun;13(6):692-8. doi: 10.1111/j.1442-2042.2006.01387.x.

  PMID: 16834644 BACKGROUND

• Zinner N, Tuttle J, Marks L. Efficacy and tolerability of darifenacin, a muscarinic M3 selective receptor antagonist (M3 SRA), compared with oxybutynin in the treatment of patients with overactive bladder. World J Urol. 2005 Sep;23(4):248-52. doi: 10.1007/s00345-005-0507-3. Epub 2005 Nov 8.

  PMID: 16096831 BACKGROUND

• Vecchioli-Scaldazza C, Morosetti C, Berouz A, Giannubilo W, Ferrara V. Solifenacin succinate versus percutaneous tibial nerve stimulation in women with overactive bladder syndrome: results of a randomized controlled crossover study. Gynecol Obstet Invest. 2013;75(4):230-4. doi: 10.1159/000350216. Epub 2013 Mar 28.

  PMID: 23548260 BACKGROUND

• Chaudhuri KR, Pal S, DiMarco A, Whately-Smith C, Bridgman K, Mathew R, Pezzela FR, Forbes A, Hogl B, Trenkwalder C. The Parkinson's disease sleep scale: a new instrument for assessing sleep and nocturnal disability in Parkinson's disease. J Neurol Neurosurg Psychiatry. 2002 Dec;73(6):629-35. doi: 10.1136/jnnp.73.6.629.

  PMID: 12438461 BACKGROUND

• Ginsberg D, Schneider T, Kelleher C, Van Kerrebroeck P, Swift S, Creanga D, Martire DL. Efficacy of fesoterodine compared with extended-release tolterodine in men and women with overactive bladder. BJU Int. 2013 Aug;112(3):373-85. doi: 10.1111/bju.12174.

  PMID: 23826844 BACKGROUND

• Coyne KS, Matza LS, Kopp Z, Abrams P. The validation of the patient perception of bladder condition (PPBC): a single-item global measure for patients with overactive bladder. Eur Urol. 2006 Jun;49(6):1079-86. doi: 10.1016/j.eururo.2006.01.007. Epub 2006 Jan 24.

  PMID: 16460875 BACKGROUND

• Coyne K, Revicki D, Hunt T, Corey R, Stewart W, Bentkover J, Kurth H, Abrams P. Psychometric validation of an overactive bladder symptom and health-related quality of life questionnaire: the OAB-q. Qual Life Res. 2002 Sep;11(6):563-74. doi: 10.1023/a:1016370925601.

  PMID: 12206577 BACKGROUND

• Cardozo L, Coyne KS, Versi E. Validation of the urgency perception scale. BJU Int. 2005 Mar;95(4):591-6. doi: 10.1111/j.1464-410X.2005.05345.x.

  PMID: 15705086 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Overactive; Parkinson Disease

Interventions

fesoterodine; Sugars

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

• Lysanne Campeau, MD, PhD

  Sir Mortimer B. Davis - Jewish General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 4, 2015
• First Posted: March 11, 2015
• Study Start: September 1, 2016
• Primary Completion: June 7, 2019
• Study Completion: June 7, 2019
• Last Updated: September 26, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)