Study of Glycopyrrolate for Moderate-to-severe Sialorrhea in Parkinson's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02382198
• Date of registration: 21/01/2015
• Prospective Registration: Yes
• Primary sponsor: Ottawa Hospital Research Institute
• Public title: Study of Glycopyrrolate for Moderate-to-severe Sialorrhea in Parkinson's Disease GLYCOPAR
• Scientific title: A Randomized, Placebo-controlled, 2-arm Parallel-group Superiority Phase II Study of GLYCOpyrrolate for Moderate-to-severe Sialorrhea in PARkinson's Disease
• Date of first enrolment: July 2016
• Target sample size: 28
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT02382198
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Canada

Contacts

• Name: Shawna Reddie

• Name: Tiago Mestre, MSc, MD
• Affiliation: The Ottawa Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- PD as defined by United Kingdom PD Society Brain Bank criteria

- Moderate-to-severe sialorrhea defined by a score in the item 2.2 of the MDS-UPDRS
greater than 2

Exclusion Criteria:

1. Other idiopathic parkinsonian syndromes, e.g., Progressive Supranuclear Palsy,
Cortico-basal syndrome, or Multiple System Atrophy

2. Secondary parkinsonian syndromes (drug-induced, traumatic, encephalitic or vascular)

3. Change in antiparkinsonian medication one month prior to enrolment

4. Prior use of glycopyrrolate with or without known hypersensitivity will be considered
an exclusion criterion, as it increases the risk of unblinding due to prior knowledge
of potential side effects or therapeutic benefit

5. Change in the dose one month prior to enrolment of other anticholinergic agents or
other drugs potentially affecting saliva production, such as tricyclic
antidepressants, MAO-A inhibitors, neuroleptics (including clozapine and quetiapine
more frequently used in PD) or hypnotics. These medication will remain in a constant
dose throughout the trial;

6. Concomitant use of solid oral dosage forms of potassium chloride;

7. Pregnancy, breastfeeding, and premenopausal females or males not using adequate
contraception; medically acceptable birth control methods for this study include: (1)
Abstinence (no sexual intercourse); (2) Intrauterine device (IUD); (3) Diaphragm with
spermicide; (4) Condom with spermicide; and (5) Oral contraceptives (birth control
pills) + condom/diaphragm with spermicide.

8. Moderate-to-severe constipation in spite of optimal treatment (MDS-UPDRS, item
1.11>2);

9. Conditions that preclude anticholinergic therapy, e.g., documented history or symptoms
suggestive of inflammatory bowel disease, glaucoma, myasthenia gravis, prostatic
hypertrophy or obstructive urinary symptoms;

10. Conditions that can be exacerbated by anticholinergic effects of glycopyrrolate, e.g.,
documented history or symptoms suggestive of congestive heart failure, coronary heart
disease, gastro-esophageal reflux disease or hyperthyroidism;

11. Uncontrolled arterial hypertension (TAS>140 mmHg or TAD>90 mmHg, using an electronic
sphygmomanometer and standardized procedure16);

12. Tachyarrhythmia (interval RR <0.6 sec.);

13. TSH<0.4 mIU/L;

14. Liver dysfunction (AST, ALT, ALP >2xUpper Normal Limit);

15. Renal dysfunction (creatinine clearance <50 mL/min), as glycopyrrolate has predominant
renal clearance;

16. Inability or unwillingness of subject or legal guardian/representative to give written
informed consent;

17. Clinical significant lactose intolerance or known hypersensitivity to any of the study
medication excipients

18. Participation in another investigational study at the time of recruitment or during
the prior month.



Age minimum: 30 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Sialorrhea

Parkinson's Disease

Intervention(s)

Drug: Placebo

Drug: Glycopyrrolate

Primary Outcome(s)

Mean sialorrhea related-disability at end of treatment (day 90) measured by the patient/caregiver-rated ROMP-saliva. [Time Frame: 90 days]

Secondary Outcome(s)

Proportion of participants with a reduction of severity of sialorrhea in at least one point from baseline to end of treatment (day 90), measured by the MDS-UPDRS, item 2.2. [Time Frame: 90 days]

Mean score in sialorrhea severity at end of treatment (day 90) measured by the sialorrhea scoring scale [Time Frame: 90 days]

Secondary ID(s)

OttawaHRI REB 2015-0043

Source(s) of Monetary Support

Please refer to primary and secondary sponsors