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Trial record 11 of 185 for:    GLYCOPYRROLATE

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

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ClinicalTrials.gov Identifier: NCT02382198
Recruitment Status : Recruiting
First Posted : March 6, 2015
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

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.

Condition or disease Intervention/treatment Phase
Sialorrhea Parkinson's Disease Drug: Glycopyrrolate Drug: Placebo Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-controlled, 2-arm Parallel-group Superiority Phase II Study of GLYCOpyrrolate for Moderate-to-severe Sialorrhea in PARkinson's Disease
Study Start Date : July 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active Group
This arm will receive the study drug glycopyrrolate.
Drug: Glycopyrrolate
Drug to reduce drooling in patients with Parkinson's Decease.

Placebo Comparator: Placebo Group
Control arm to receive placebo
Drug: Placebo



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

Secondary Outcome Measures :
  1. Mean score in sialorrhea severity at end of treatment (day 90) measured by the sialorrhea scoring scale [ Time Frame: 90 days ]
  2. 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 ]


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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02382198


Contacts
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Contact: Shawna Reddie 613-798-5555 ext 19369 sreddie@ohri.ca
Contact: Tiago Mestre, MSc, MD 613-798-5555 ext 18986 tmestre@toh.ca

Locations
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Canada, Ontario
The Ottawa Hospital - Civic Campus Recruiting
Ottawa, Ontario, Canada, K1Y 4E9
Contact: Shawna Reddie    613-798-5555 ext 19369    sreddie@ohri.ca   
Contact: Tiago Mestre, MSc, MD    613-798-5555 ext 18986    tmestre@toh.ca   
Principal Investigator: Tiago Mestre, MSc, MD         
Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Alison Tian    416-603-5800 ext 3415    Alison.Tian@uhnresearch.ca   
Contact: Susan Fox, MBChB, MRCP, PhD    416-699-9837    Sfox@uhnresearch.ca   
Principal Investigator: Susan Fox, MBChB, MRCP, PhD         
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
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Principal Investigator: Tiago Mestre, MSc, MD The Ottawa Hospital

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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02382198     History of Changes
Other Study ID Numbers: OttawaHRI REB 2015-0043
First Posted: March 6, 2015    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Ottawa Hospital Research Institute:
droooling, sialorrhea, parkinson's disease, parkinsons
Additional relevant MeSH terms:
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Glycopyrrolate
Sialorrhea
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs