The aim of this study is to prove the efficacy of 3 times daily 1 mg glycopyrronium bromide versus placebo in patients with PD with hypersalivation. Furthermore, the safety of glycopyrronium bromide used in the mentioned dosage will be further…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage of patients with a decrease of 3 points on the hypersalivation score
(on a scale from 1-9).
Secondary outcome
The difference in mean improvement on the hypersalivation score between the two
groups. Furthermore, the difference in reported adverse events will be
analysed.
Background summary
75% of patients with Parkinson's disease (PD) do suffer from hypersalivation.
There are several symptomatic treatments for hypersalivation by decreasing the
amount of water in saliva. Until now there is not a registered drug available
in the treatment of hypersalivation. Most drugs used have disadvantages, such
as central side effects. Glycopyrroniumbromide is a quartenair anticholinergic
drug, that does only slightly pass the blood-brain barrier. The chance of
central side effects is therefore lower. Formerly, there was a
glycopyrroniumbromide injection available for the treatment of hypersalivation
in patient undergoing surgery under anesthesia. This product was withdrawn
because of commercial reasons in 2003. Neurologist in hospital Medisch Spectrum
Twente have a good experience with oral glycopyrroniumbromide. However, the
effect of oral glycopyrroniumbromide on hypersalivation has never been proved
in patients with PD. Positive effects have been found with oral
glycopyrroniumbromide in other patients with hypersalivation (e.g. patients
with cerebral palsy).
Study objective
The aim of this study is to prove the efficacy of 3 times daily 1 mg
glycopyrronium bromide versus placebo in patients with PD with hypersalivation.
Furthermore, the safety of glycopyrronium bromide used in the mentioned dosage
will be further evaluated. In addition, the aim is to perform a pharmacogenetic
analysis with these data within the purpose of this study.
Study design
This is a randomised, double-blind, placebocontrolled, cross-over study. It
will take 5 weeks per patient. In week 1 there are baseline measurements, in
week 2 glycopyrroniumbromide or placebo will be taken, in week 3 there are new
baseline measurements, in week 4 cross-over glycopyrroniumbromide or placebo
will be taken. The final visit will be in week 5. Patients score the extent of
hypersalivation three times a day on a daily basis (scale from 1-9).
Intervention
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 5ml daily).
Study burden and risks
The main risks are the adverse effects of glycopyrroniumbromide. In trials with
orally used glycopyrroniumbromide the adverse effects were mainly: dry mouth,
miction problems, nausea and nervosity. The blood collection may result in a
bruce.
Postbus 50.000
7500 KA Enschede
Nederland
Postbus 50.000
7500 KA Enschede
Nederland
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2006-005596-18-NL |
| CCMO | NL14912.044.06 |