The effect of glycopyrronium bromide on hypersalivation in patients with Parkinson's disease: a randomised, cross-over, double blind, placebo-controlled trial
| ISRCTN | ISRCTN28592111 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28592111 |
| Secondary identifying numbers | APOMST001, NL848, NTR862 |
- Submission date
- 08/02/2007
- Registration date
- 08/02/2007
- Last edited
- 15/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr P J E Poels
Scientific
Scientific
Hospital Medisch Spectrum Twente
Department of Neurology
P.O. Box 50000
Enschede
7500 KA
Netherlands
Study information
| Study design | Randomised, placebo-controlled, cross-over group, double blinded trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | The effect of glycopyrronium bromide on hypersalivation in patients with Parkinson's disease: a randomised, cross-over, double blind, placebo-controlled trial |
| Study acronym | Glyspar study |
| Study objectives | The aim of this study is to prove the efficacy of three times daily 1 mg glycopyrronium bromide admixture versus placebo admixture in patients with Parkinson's Disease (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. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Parkinsonian patients, hypersalivation |
| Intervention | Week one: baseline measurements Week two: glycopyrronium bromide (three times 1 mg [5 ml] daily) or placebo (three times 5 ml daily) will be taken Week three: new baseline measurements Week four: cross-over glycopyrronium bromide (three times 1 mg [5 ml] daily) or placebo (three times 5 ml daily) will be taken Week five: final visit Patients score the extent of hypersalivation three times a day on a daily basis (scale from one to nine). |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Glycopyrronium bromide |
| Primary outcome measure | Percentage of patients with a decrease of three points on the hypersalivation score (on a scale from one to nine). |
| Secondary outcome measures | The difference in mean improvement on the hypersalivation score between the two groups. Furthermore, the difference in reported adverse events will be analysed. |
| Overall study start date | 01/02/2007 |
| Completion date | 01/01/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 24 |
| Total final enrolment | 23 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/02/2007 |
| Date of final enrolment | 01/01/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Hospital Medisch Spectrum Twente
Enschede
7500 KA
Netherlands
7500 KA
Netherlands
Sponsor information
Hospital Medisch Spectrum Twente (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Clinical Pharmacy
P.O. Box 50000
Enschede
7500 KA
Netherlands
| Website | http://www.ziekenhuis-mst.nl/ |
|---|---|
"ROR" |
https://ror.org/033xvax87 |
Funders
Funder type
Hospital/treatment centre
Hospital Medisch Spectrum Twente (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 13/04/2010 | 15/01/2021 | Yes | No |
Editorial Notes
15/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NTR numbers have been added.
