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Sponsors and Collaborators: |
University Health Network, Toronto Parkinson's Disease Foundation |
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Information provided by: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT00296946 |
A phase II double blind clinical trial investigating the effects of ipratropium spray versus placebo spray in patients with Parkinson's disease.
Condition | Intervention | Phase |
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Parkinson's Disease |
Drug: ipratropium bromide (drug) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Phase II Clinical Trial of Ipratropium Bromide Spray as a Treatment for Sialorrhea in Patients With Parkinson's Disease |
Estimated Enrollment: | 20 |
Study Start Date: | November 2004 |
Estimated Study Completion Date: | June 2006 |
Background: Excessive drooling of saliva (sialorrhoea) is a common complication of Parkinson’s disease (PD). Unfortunately current medications, which rely on anticholinergic properties, often induce systemic side effects, such as confusion, hallucinations or urinary retention.
Aim: We therefore hypothesise that local application of an anticholinergic aerosol spray into the mouth would reduce sialorrhea in PD without inducing systemic side-effects.
Method: A double blind, randomised, placebo-controlled cross-over trial of the muscarinic antagonist, ipratropium bromide in patients with bothersome drooling in idiopathic Parkinson’s disease. All patients are recruited from the Movement Disorders Clinic, Toronto Western Hospital and informed consent is obtained. Patients are randomised to receive ipratropium bromide, 1- 2 metered doses (sprays) of active drug (21 g per metered dose) or matching placebo, up to a maximum of 4 times per day, in a double-blind, cross-over design using randomisation tables. Total treatment length is two weeks for each limb of the study with a 1-2 week wash out period. The primary outcome measure is an objective measure of saliva production. Dental rolls are inserted into the mouth for 5 min and the patient instructed not to swallow and sit upright. The weight of dental rolls before and after insertion is calculated as a measure of saliva production. The secondary outcome measures are subjective measure of saliva where patients or caregivers record the level of saliva production each day for the 2 weeks of each treatment using validated subjective rating scales which assess drooling severity and frequency. In addition, parkinsonism is rated using the UPDRS parts I – IV and adverse events are recorded. The scores for measured saliva production following ipratropium bromide and placebo treatment will be compared using appropriate paired t-tests. Results from the scales assessing the subjective measures of saliva production and UPDRS ratings will be compared via paired non-parametric Wilcoxon matched pairs test. 20 patients will be recruited.
Ages Eligible for Study: | 30 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:Male and female patients with idiopathic PD and who are currently experiencing bothersome drooling (United Parkinson’s Disease Rating Scale (UPDRS) item 6, rating of 2 or higher) will be eligible for this study. Patients must be on a stable medication regimen for the preceding one-month run-in period. In addition, patients or a caregiver must be able to complete a daily record card, and patients must be able to tolerate an oral dental roll for 5-minute periods for saliva measurements.
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Exclusion Criteria:
Patients taking acetylcholinesterase inhibitors, cholinergic agents, or anticholinergic agents, history of glaucoma, clinically significant urinary outflow obstruction or urinary retention, active psychosis or hallucinations, and allergy to peanuts or soybeans. -
Canada, Ontario | |
Toronto Western Hospital, University Health Network | |
Toronto, Ontario, Canada, M5T 2S8 |
Principal Investigator: | Susan H Fox, MRCP, PhD | University Health Network, Toronto, Canada |
Study ID Numbers: | FY2005 |
Study First Received: | February 23, 2006 |
Last Updated: | November 15, 2006 |
ClinicalTrials.gov Identifier: | NCT00296946 |
Health Authority: | Canada: Health Canada |
Sialorrhoea |
Sialorrhea Ganglion Cysts Ipratropium Bromides Movement Disorders Parkinson Disease |
Basal Ganglia Diseases Central Nervous System Diseases Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases |
Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Nervous System Diseases Physiological Effects of Drugs Anti-Asthmatic Agents Cholinergic Agents |
Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Central Nervous System Agents Bronchodilator Agents Anticonvulsants |