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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.
To assses if Glycopyrrolate has a long lasting effect on sialorrhea for patients with Parkinsons.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Group | Active Comparator | This arm will receive the study drug glycopyrrolate. |
|
| Placebo Group | Placebo Comparator | Control arm to receive placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glycopyrrolate | Drug | Drug to reduce drooling in patients with Parkinson's Decease. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean sialorrhea related-disability at end of treatment (day 90) measured by the patient/caregiver-rated ROMP-saliva. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shawna Reddie | Contact | 613-798-5555 | 19369 | sreddie@ohri.ca |
| Tiago Mestre, MSc, MD | Contact | 613-798-5555 | 18986 | tmestre@toh.ca |
| Name | Affiliation | Role |
|---|---|---|
| Tiago Mestre, MSc, MD | The Ottawa Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital - Civic Campus | Recruiting | Ottawa | Ontario | K1Y 4E9 | Canada |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 7, 2020 | |
| Reset | Dec 30, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 7, 2020 | Dec 30, 2020 |
| ID | Term |
|---|---|
| D012798 | Sialorrhea |
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D020734 | Parkinsonian Disorders |
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| ID | Term |
|---|---|
| D006024 | Glycopyrrolate |
| ID | Term |
|---|---|
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
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| Placebo |
| Drug |
|
| 90 days |
| Toronto Western Hospital | Recruiting | Toronto | Ontario | M5T 2S8 | Canada |
|
| D001480 |
| Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D011759 |
| Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |