No registrations found.
ID
Source
Brief title
Health condition
Parkinsonian patients with hypersalivation
Sponsors and support
Hospital Medisch Spectrum TwenteDepartment of clinical pharmacy
P.O. Box 50.000
7500 KA Enschede
The Netherlands
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
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. 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).
Study objective
The aim of this study is to prove the efficacy of 3 times daily 1 mg glycopyrronium bromide admixture versus placebo admixture 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.
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).
Department of neurology
P.O. Box 50.000
P.J.E. Poels
Enschede 7500 KA
The Netherlands
+31 53 4872000
Department of neurology
P.O. Box 50.000
P.J.E. Poels
Enschede 7500 KA
The Netherlands
+31 53 4872000
Inclusion criteria
1. Patients with Parkinson's disease;
2. Age >=18 years;
3. Hypersalivation score >=5 (on a scale from 1-9);
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 rythm disorders;
6. Glaucoma;
7. Pylorus stenosis;
8. Paralytic ileus;
9. Prostate hypertrophy;
10 Patients using potassiumchloride tablets, oral digoxin or oral corticosteroids;
11. Kidney function disorders;
12. Pregnancy or lactation.
Design
Recruitment
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 |
|---|---|
| NTR-new | NL848 |
| NTR-old | NTR862 |
| Other | : APOMST001 |
| ISRCTN | ISRCTN28592111 |