The effect of INhaled Glycopyrronium bromide on Excessive Sialorrhea and Drooling in Parkinson disease: a dose finding study
Phase 2
Completed
- Conditions
- Sialorrhea and drooling1003940410028037
- Registration Number
- NL-OMON45524
- Lead Sponsor
- Medisch Spectrum Twente
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
Diagnosed with Parkinson disease
Moderate to severe sialorrhea, defined as a minimum of 4 on the Mier scale. Age > 18 years
Able to fill the scoring table (or the partner/carer must be able to)
Exclusion Criteria
Hypersensitivity to glycopyrronium or other excipients
Use of medication with known anticholinergic effects
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the determination of the safety and tolerability of<br /><br>glycopyrronium inhalations in PD patients with sialorrhea. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary endpoints are to determine mean difference in loss of saliva<br /><br>between dosing regimens and baseline week and to investigate the preferred<br /><br>method of treatment by patients.</p><br>