Clinical Trial: Study of Glycopyrrolate for Moderate-to-severe Sialorrhea in Parkinson's Disease
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Randomized, Placebo-controlled, 2-arm Parallel-group Superiority Phase II Study of GLYCOpyrrolate for Moderate-to-severe Sialorrhea in PARkinson's Disease
Brief Summary: Sialorrhea is a frequently occurring problem with detrimental effect on quality of life in 25% of PD patients. Currently, there is no intervention approved for sialorrhea in Parkinsons and evidence is only available for a 30-day effect or less. We hypothesize that glycopyrrolate will have a lasting effect in the reduction of sialorrhea in PD patients.
Detailed Summary: To assses if Glycopyrrolate has a long lasting effect on sialorrhea for patients with Parkinsons.
Sponsor: Ottawa Hospital Research Institute
Current Primary Outcome: Mean sialorrhea related-disability at end of treatment (day 90) measured by the patient/caregiver-rated ROMP-saliva. [ Time Frame: 90 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Mean score in sialorrhea severity at end of treatment (day 90) measured by the sialorrhea scoring scale [ Time Frame: 90 days ]
- Proportion of participants with a reduction of severity of sialorrhea in at least one point from baseline to end of treatment (day 90), measured by the MDS-UPDRS, item 2.2. [ Time Frame: 90 days ]
Original Secondary Outcome: Same as current
Information By: Ottawa Hospital Research Institute
Dates:
Date Received: January 21, 2015
Date Started: July 2016
Date Completion: July 2017
Last Updated: September 13, 2016
Last Verified: August 2016
