SialorrheaPhase 2GLYCOPARNCT02382198
Study of Glycopyrrolate for Moderate-to-severe Sialorrhea in Parkinson's Disease
A Phase 2 study testing Glycopyrrolate in people with Sialorrhea and Parkinson's Disease, run by Ottawa Hospital Research Institute at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Sialorrhea, Parkinson's Disease
- What is being tested?
- Glycopyrrolate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 2 sitesCanada
- Study dates
- Jul 2016to Dec 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- 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
- 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;
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- 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;
- Clinical significant lactose intolerance or known hypersensitivity to any of the study medication excipients
- Participation in another investigational study at the time of recruitment or during the prior month.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
The Ottawa Hospital - Civic Campus
Ottawa, Ontario, K1Y 4E9
Shawna Reddie, 613-798-5555 ext. 19369, sreddie@ohri.ca
Tiago Mestre, MSc, MD, 613-798-5555 ext. 18986, tmestre@toh.ca
- Recruiting
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Alison Tian, 416-603-5800 ext. 3415, Alison.Tian@uhnresearch.ca
Susan Fox, MBChB, MRCP, PhD, 416-699-9837, Sfox@uhnresearch.ca
About this study
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
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.
Read the detailed description
To assses if Glycopyrrolate has a long lasting effect on sialorrhea for patients with Parkinsons.
- Conditions
- Sialorrhea, Parkinson's Disease
- Being tested
- Glycopyrrolate, Placebo
- Keywords
- droooling, sialorrhea, parkinson's disease, parkinsons
- Medical subject headings
- Sialorrhea, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlycopyrrolateDrug
Drug to reduce drooling in patients with Parkinson's Decease.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Active Group | Active comparator | This arm will receive the study drug glycopyrrolate. Receives: Drug: Glycopyrrolate |
| Placebo Group | Placebo comparator | Control arm to receive placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean sialorrhea related-disability at end of treatment (day 90) measured by the patient/caregiver-rated ROMP-saliva.
Measured: 90 days
Secondary outcomes (2)
Mean score in sialorrhea severity at end of treatment (day 90) measured by the sialorrhea scoring scale
Measured: 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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startJul 2016
- Primary completionOct 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SialorrheaStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tiago Mestre, MSc, MD, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02382198
- Sponsor's protocol ID
- OttawaHRI REB 2015-0043
- Acronym
- GLYCOPAR
- Status last verified
- Apr 2018
- First submitted
- 21 Jan 2015
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02382198
- Acronym / sponsor ID
- GLYCOPAR / OttawaHRI REB 2015-0043
- Conditions
- Sialorrhea, Parkinson's Disease
- Keywords
- droooling, sialorrhea, parkinson's disease, parkinsons
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 6 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Group | Active comparator | Drug: GlycopyrrolateThis arm will receive the study drug glycopyrrolate. |
| Placebo Group | Placebo comparator | Drug: PlaceboControl arm to receive placebo |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (18 listed)
- 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
- 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
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlycopyrrolateDrug to reduce drooling in patients with Parkinson's Decease. | Drug | Active Group |
| Placebo | Drug | Placebo Group |
Primary outcome
Mean sialorrhea related-disability at end of treatment (day 90) measured by the patient/caregiver-rated ROMP-saliva.
Time frame: 90 days
2 secondary outcomes
Mean score in sialorrhea severity at end of treatment (day 90) measured by the sialorrhea scoring scale
Time frame: 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.
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Sialorrhea
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Effects of Transcutaneous Vagus Nerve Stimulation in Parkinson´s Disease
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Application of Neuro-electrostimulation as a Treatment for Patients With Dry Mouth
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Effectiveness of Neuromuscular Electrical Stimulation Added to Oral Motor Therapy in Cerebral Palsy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiago Mestre, MSc, MD principal investigator
The Ottawa Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Glycopyrrolate in people with Sialorrhea and Parkinson's Disease, run by Ottawa Hospital Research Institute at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shawna Reddie (613-798-5555 ext. 19369, sreddie@ohri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean sialorrhea related-disability at end of treatment (day 90) measured by the patient/caregiver-rated ROMP-saliva. (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.