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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00906828 |
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Date of registration:
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19/05/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Pharmacokinetics of Levodopa/Carbidopa Infusion With and Without Oral Catechol-O-methyl Transferase (COMT) Inhibitors
DuoCOMT |
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Scientific title:
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Pharmacokinetics of Levodopa in Patients With Parkinson's Disease Treated With Levodopa/Carbidopa Infusion With and Without Oral COMT Inhibitors |
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Date of first enrolment:
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October 2008 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00906828 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Dag Nyholm, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Uppsala University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Parkinson's disease
- Duodopa treatment ongoing
- Hoehn & Yahr stage 3-5 at worst
Exclusion Criteria:
- Ongoing treatment with COMT inhibitors
- Dementia
- Psychosis
- Treatment with typical neuroleptics
- Contraindications for entacapone or tolcapone
Age minimum:
30 Years
Age maximum:
90 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Parkinson Disease
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Intervention(s)
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Drug: entacapone
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Drug: levodopa/carbidopa
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Drug: tolcapone
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Primary Outcome(s)
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Difference in coefficient of variation of levodopa in plasma between baseline (day 1) and each of the days on COMT inhibitors.
[Time Frame: 3 days]
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Secondary Outcome(s)
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Difference in Treatment Response Scale between the treatments.
[Time Frame: 3 days]
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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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