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

NCT02382198 | Unknown Phase 2 DMC

• 1 other identifier: OttawaHRI REB 2015-0043
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

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

Keywords

droooling, sialorrhea, parkinson's disease, parkinsons

Outcome Measures

Primary Outcomes (1)

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

  90 days

Secondary Outcomes (2)

• Mean score in sialorrhea severity at end of treatment (day 90) measured by the sialorrhea scoring scale

  90 days

• 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.

  90 days

Study Arms (2)

Active Group

ACTIVE COMPARATOR

This arm will receive the study drug glycopyrrolate.

Drug: Glycopyrrolate

Placebo Group

PLACEBO COMPARATOR

Control arm to receive placebo

Drug: Placebo

Interventions

Glycopyrrolate DRUG

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

Active Group

Placebo DRUG

Placebo Group

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Other idiopathic parkinsonian syndromes, e.g., Progressive Supranuclear Palsy, Cortico-basal syndrome, or Multiple System Atrophy
• Secondary parkinsonian syndromes (drug-induced, traumatic, encephalitic or vascular)
• Change in antiparkinsonian medication one month prior to enrolment
• 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;
• Concomitant use of solid oral dosage forms of potassium chloride;
• 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.
• Moderate-to-severe constipation in spite of optimal treatment (MDS-UPDRS, item 1.11\>2);
• 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;
• 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;
• Uncontrolled arterial hypertension (TAS\>140 mmHg or TAD\>90 mmHg, using an electronic sphygmomanometer and standardized procedure16);
• Tachyarrhythmia (interval RR \<0.6 sec.);
• TSH\<0.4 mIU/L;
• Liver dysfunction (AST, ALT, ALP \>2xUpper Normal Limit);
• Renal dysfunction (creatinine clearance \<50 mL/min), as glycopyrrolate has predominant renal clearance;
• Inability or unwillingness of subject or legal guardian/representative to give written informed consent;

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (2)

The Ottawa Hospital - Civic Campus

Ottawa, Ontario, K1Y 4E9, Canada

RECRUITING

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

MeSH Terms

Conditions

Sialorrhea; Parkinson Disease

Interventions

Glycopyrrolate

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Tiago Mestre, MSc, MD

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shawna Reddie

CONTACT

613-798-5555; sreddie@ohri.ca

Tiago Mestre, MSc, MD

CONTACT

613-798-5555; tmestre@toh.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2015
• First Posted: March 6, 2015
• Study Start: July 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 17, 2018

Record last verified: 2018-04

Locations

CA (2)