The effect of glycopyrronium bromide on hypersalivation in patients with Parkinson's disease: a randomised, cross-over, double blind, placebo-controlled trial

Not Applicable

Completed

• Conditions: Parkinsonian patients, hypersalivation; Nervous System Diseases; Extrapyramidal and movement disorders

• Registration Number: ISRCTN28592111
• Lead Sponsor: Hospital Medisch Spectrum Twente (The Netherlands)

Brief Summary

2010 results in https://pubmed.ncbi.nlm.nih.gov/20385892/ (added 15/01/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-02-08
• Study Completion: 2009-01-01
• Last Update Posted: 25 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 23

Inclusion Criteria

1. Patients with Parkinson's disease
2. Aged more than or equal to 18 years
3. Hypersalivation score more than or equal to five (on a scale from one to nine)
4. Patient or family is able to score the extent of hypersalivation

Exclusion Criteria

1. Hypersensitivity to glycopyrronium bromide, sorbic acid or saccharin sodium
2. Myasthenia gravis
3. Symptomatic tachycardia
4. Coronary insufficiency
5. Heart rhythm disorders
6. Glaucoma
7. Pylorus stenosis
8. Paralytic ileus
9. Prostate hypertrophy
10 Patients using potassium chloride tablets, oral digoxin or oral corticosteroids
11. Kidney function disorders
12. Pregnancy or lactation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients with a decrease of three points on the hypersalivation score (on a scale from one to nine).

Secondary Outcome Measures

Name	Time	Method
The difference in mean improvement on the hypersalivation score between the two groups. Furthermore, the difference in reported adverse events will be analysed.