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

NCT ID: NCT02382198

Last Updated: 2018-04-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2018-12-31

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.

Detailed Description

To assses if Glycopyrrolate has a long lasting effect on sialorrhea for patients with Parkinsons.

Conditions

Sialorrhea; Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active Group

This arm will receive the study drug glycopyrrolate.

Group Type: ACTIVE_COMPARATOR

Glycopyrrolate

Intervention Type: DRUG

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

Placebo Group

Control arm to receive placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Glycopyrrolate

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

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tiago Mestre, MSc, MD

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital

Locations

The Ottawa Hospital - Civic Campus

Ottawa, Ontario, Canada

Site Status: RECRUITING

Toronto Western Hospital

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Shawna Reddie

Role: CONTACT

sreddie@ohri.ca

613-798-5555 ext. 19369

Tiago Mestre, MSc, MD

Role: CONTACT

tmestre@toh.ca

613-798-5555 ext. 18986

Facility Contacts

Shawna Reddie

Role: primary

sreddie@ohri.ca

613-798-5555 ext. 19369

Tiago Mestre, MSc, MD

Role: backup

tmestre@toh.ca

613-798-5555 ext. 18986

Alison Tian

Role: primary

Alison.Tian@uhnresearch.ca

416-603-5800 ext. 3415

Susan Fox, MBChB, MRCP, PhD

Role: backup

Sfox@uhnresearch.ca

416-699-9837

Other Identifiers

OttawaHRI REB 2015-0043

Identifier Type: -

Identifier Source: org_study_id