Condition category
Nervous System Diseases
Date applied
08/02/2007
Date assigned
08/02/2007
Last edited
08/02/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr P J E Poels

ORCID ID

Contact details

Hospital Medisch Spectrum Twente
Department of Neurology
P.O. Box 50000
Enschede
7500 KA
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

APOMST001

Study information

Scientific title

Acronym

Glyspar study

Study hypothesis

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

Ethics approval received from the local medical ethics committee

Study design

Randomised, placebo-controlled, cross-over group, double blinded trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Glycopyrronium bromide

Primary outcome measures

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 trial start date

01/02/2007

Overall trial end date

01/01/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

24

Participant 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

Recruitment start date

01/02/2007

Recruitment end date

01/01/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

Hospital Medisch Spectrum Twente
Enschede
7500 KA
Netherlands

Sponsor information

Organisation

Hospital Medisch Spectrum Twente (The Netherlands)

Sponsor details

Department of Clinical Pharmacy
P.O. Box 50000
Enschede
7500 KA
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.ziekenhuis-mst.nl/

Funders

Funder type

Hospital/treatment centre

Funder name

Hospital Medisch Spectrum Twente (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes