Status:
COMPLETED
Ipratropium Spray for Drooling Saliva in Parkinson's Disease
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Parkinson's Disease Foundation
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE2
Brief Summary
A phase II double blind clinical trial investigating the effects of ipratropium spray versus placebo spray in patients with Parkinson's disease.
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 s...
Eligibility Criteria
Inclusion
- 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
- 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. -
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00296946
Start Date
November 1 2004
End Date
June 1 2006
Last Update
February 20 2018
Active Locations (1)
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1
Toronto Western Hospital, University Health Network
Toronto, Ontario, Canada, M5T 2S8