The effect of glycopyrronium bromide on hypersalivation in patients with Parkinson's disease: a randomised, cross-over, double-blind, placebo controlled trial.
Phase 2
Completed
- Conditions
- droolingHypersalivation10028037
- Registration Number
- NL-OMON30532
- Lead Sponsor
- Medisch Spectrum Twente
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
- Patients with Parkinson's disease
- Age >=18 years
- Hypersalivation score >=5 (on a scale from 1-9)
- Patient or family is able to score the extent of hypersalivation
Exclusion Criteria
- Hypersensitivity to glycopyrronium bromide, sorbic acid or saccharin sodium
- Myasthenia gravis
- Tachycardia
- Coronary insufficiency
- Glaucoma
- Pylorus stenosis
- Paralytic ileus
- Prostate hypertrophy
- Pregnancy or lactation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Percentage of patients with a decrease of 3 points on the hypersalivation score<br /><br>(on a scale from 1-9).</p><br>
- Secondary Outcome Measures
Name Time Method <p>The difference in mean improvement on the hypersalivation score between the two<br /><br>groups. Furthermore, the difference in reported adverse events will be<br /><br>analysed.</p><br>