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Study of Glycopyrrolate for Moderate-to-severe Sialorrhea in Parkinson's Disease | Clinical Trials | Clareo Health

UNKNOWNPHASE2

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

A Randomized, Placebo-controlled, 2-arm Parallel-group Superiority Phase II Study of GLYCOpyrrolate for Moderate-to-severe Sialorrhea in PARkinson's Disease

NCT02382198•Ottawa Hospital Research Institute

View on ClinicalTrials.gov

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.

Eligibility

Age

30 - No limit years

Sex

ALL

Healthy Volunteers

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;
+8 more criteria

Locations (2)

The Ottawa Hospital - Civic Campus

Ottawa, Ontario, Canada

Toronto Western Hospital

Toronto, Ontario, Canada

Key Dates

Start Date

July 1, 2016

Primary Completion Date

October 1, 2018

Completion Date

December 1, 2018

Last Updated

April 17, 2018

Enrollment

ESTIMATED participants

Conditions

SialorrheaParkinson's Disease

Interventions

Glycopyrrolate

DRUG

Placebo

DRUG

Contacts

Shawna Reddie

CONTACT

613-798-5555 sreddie@ohri.ca

Tiago Mestre, MSc, MD

CONTACT

613-798-5555 tmestre@toh.ca

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 17, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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