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Tracking Information | |||||
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First Received Date † | February 23, 2006 | ||||
Last Updated Date | November 15, 2006 | ||||
Start Date † | November 2004 | ||||
Current Primary Outcome Measures † |
objective measure of saliva production. | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00296946 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Ipratropium Spray for Drooling Saliva in Parkinson's Disease | ||||
Official Title † | Phase II Clinical Trial of Ipratropium Bromide Spray as a Treatment for Sialorrhea in Patients With Parkinson's Disease | ||||
Brief Summary | A phase II double blind clinical trial investigating the effects of ipratropium spray versus placebo spray in patients with Parkinson's disease. |
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Detailed Description | 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. |
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Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study | ||||
Condition † | Parkinson's Disease | ||||
Intervention † | Drug: ipratropium bromide (drug) | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 20 | ||||
Completion Date | June 2006 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | 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. - 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. - |
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Gender | Both | ||||
Ages | 30 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | Canada | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00296946 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | University Health Network, Toronto | ||||
Collaborators †† | Parkinson's Disease Foundation | ||||
Investigators † |
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Information Provided By | University Health Network, Toronto | ||||
Verification Date | October 2004 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |