Recruiting
Phase 2

Glycopyrrolate

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT02382198

Conditions

Sialorrhea

Parkinson's Disease

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Not accepted

Interventions

Glycopyrrolate

Placebo

Study Details

Brief summary:

Sialorrhea is a frequently occurring problem with detrimental effect on quality of life in 25% of PD patients. Currently, there is no intervention approved for sialorrhea in Parkinsons and evidence is only available for a 30-day effect or less. We hypothesize that glycopyrrolate will have a lasting effect in the reduction of sialorrhea in PD patients.

Conditions

Sialorrhea

Parkinson's Disease

Study ID

NCT02382198

Start date

Jul, 2016

Status verified date

Apr, 2018

Completion date

Dec, 2018

Anticipated

Primary completion date

Oct, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

28 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Active Group

This arm will receive the study drug glycopyrrolate.

placebo comparator: Placebo Group

Control arm to receive placebo

Interventions

Glycopyrrolate

Drug to reduce drooling in patients with Parkinson's Decease.

Placebo

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

The Ottawa Hospital - Civic Campus

Recruiting

Ottawa, Ontario, Canada, K1Y 4E9

Contacts

Principal Investigator:

Tiago Mestre, MSc, MD

Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Principal Investigator:

Susan Fox, MBChB, MRCP, PhD

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Apr 17, 2018

Last verified

Apr, 2018

Keywords

  • droooling, sialorrhea, parkinson's disease, parkinsons

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2018-04-17.