| - candidate number | 2430 |
| - NTR Number | NTR862 |
| - ISRCTN | ISRCTN28592111 |
| - Date ISRCTN created | 8-feb-2007 |
| - date ISRCTN requested | 7-feb-2007 |
| - Date Registered NTR | 24-jan-2007 |
| - Secondary IDs | APOMST001 |
| - Public Title | The effect of glycopyrroniumbromide on hypersalivation in patients with Parkinson's disease: a randomised, cross-over, doubleblind, placebocontrolled trial. |
| - Scientific Title | The effect of glycopyrroniumbromide on hypersalivation in patients with Parkinson's disease: a randomised, cross-over, doubleblind, placebocontrolled trial. |
| - ACRONYM | Glyspar study |
| - hypothesis | 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. |
| - Healt Condition(s) or Problem(s) studied | Hypersalivation, Parkinson patient |
| - 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. |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | Triple |
| - control | Placebo |
| - group | Crossover |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-feb-2007 |
| - planned closingdate | 1-jan-2009 |
| - Target number of participants | 24 |
| - 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 5ml daily). |
| - 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. |
| - Timepoints | |
| - Trial web site | N/A |
| - status | stopped: trial finished |
| - CONTACT FOR PUBLIC QUERIES | Dr. P.J.E. Poels |
| - CONTACT for SCIENTIFIC QUERIES | M.E.L. Arbouw |
| - Sponsor/Initiator | Hospital Medisch Spectrum Twente, Department of clinical pharmacy |
| - Funding (Source(s) of Monetary or Material Support) | Hospital Medisch Spectrum Twente, Department of clinical pharmacy |
| - Publications | N/A |
| - Brief 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). |
| - Main changes (audit trail) | |
| - RECORD | 24-jan-2007 - 28-nov-2008 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl