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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON30532

Enrollment

Registered

2006-11-13

Start date

2007-02-15

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

drooling Hypersalivation

Interventions

Cross over design: In week 2 glycopyrroniumbromide (3 times 1mg=5ml daily ) or placebo (3 times 5ml daily ). In week 4 cross-over glycopyrroniumbromide (3 times 1mg=5ml daily ) or placebo (3 times 5

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Percentage of patients with a decrease of 3 points on the hypersalivation score (on a scale from 1-9).	—

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)