Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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16 December 2017 |
Main ID: |
NCT01738178 |
Date of registration:
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28/11/2012 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Caffeine as a Therapy for Parkinson's Disease
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Scientific title:
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Caffeine as a Therapeutic Agent in Parkinson's Disease |
Date of first enrolment:
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April 2014 |
Target sample size:
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119 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT01738178 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 3
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Countries of recruitment
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Brazil
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Canada
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Contacts
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Name:
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Ronald B Postuma, MD, MSc |
Address:
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Telephone:
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Email:
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Affiliation:
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Research Insitute of the MUHC |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
All patients must have idiopathic PD diagnosed as parkinsonism according to the UK brain
bank criteria, and PD considered the likeliest underlying cause according to the treating
physician. Other inclusion criteria include:
1. PD diagnosis: between 6 months and 8 years
2. Hoehn and Yahr stage I-III
3. Age at least 45 and less than 75 (to optimize survival over the 5-year trial).
4. Receiving symptomatic therapy for PD for at least 6 months. Dose must have been stable
over the previous 3 months.
Exclusion Criteria:
1. Caffeine intake >150 mg per day (i.e. more than one cup of filtered coffee per day) or
prescribed adenosine antagonists - caffeine intake will be measured by a standardized
intake questionnaire. Intake will be converted into estimated caffeine mg dose by
standard caffeine-content charts.
2. Active peptic ulcer disease, or symptomatic gastroesophageal reflux disease.
3. Supraventricular cardiac arrhythmia (such as atrial fibrillation or atrial flutter) -
Electrocardiogram will be measured at baseline to rule out supraventricular
tachycardia.
4. Uncontrolled hypertension - systolic bp >170 or diastolic bp >110 on two readings.
5. Pre-menopausal women who are not using effective methods of birth control
6. Cognitive impairment, defined as MoCA <23/30.
7. Moderate-Severe Depression, as defined by a Beck Depression Inventory score of >19.
8. Changes to antiparkinsonian medication in the last 3 months, or changes to
antiparkinsonian medication are anticipated during the next six months.
9. Current use of lithium or clozapine (pharmacokinetic interactions).
Age minimum:
45 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Intervention(s)
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Drug: Placebo
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Drug: Caffeine
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Primary Outcome(s)
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Motor manifestations associated with Parkinson's disease
[Time Frame: every 6 months]
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Secondary Outcome(s)
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Sleep
[Time Frame: every 6 motnhs]
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Cognition
[Time Frame: every 6 months]
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Quality of life
[Time Frame: every 6 months]
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MDS-UPDRS components and subscales - each individual component will be assessed, including:
[Time Frame: every 6 months]
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Medication utilization
[Time Frame: evry 6 months]
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Tolerability and side effects of caffeine
[Time Frame: every 6 motnhs]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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