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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 October 2017 |
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Main ID: |
NCT00501969 |
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Date of registration:
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16/07/2007 |
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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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An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advanced-Stage Parkinson's Disease
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Scientific title:
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An Open-Label Extension to the Double-Blind SP515 (NCT00244387) Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Advanced-Stage Idiopathic Parkinson's Disease Who Are Not Well Controlled on L-Dopa |
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Date of first enrolment:
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August 2004 |
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Target sample size:
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395 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00501969 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Australia
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Austria
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Croatia
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Czech Republic
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Finland
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France
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Germany
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Hungary
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Israel
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Italy
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New Zealand
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Norway
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Poland
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South Africa
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Spain
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Sweden
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United Kingdom
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Contacts
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Name:
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UCB Clinical Trial Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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+1 877 822 9493 (UCB) |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subjects who have completed four months of maintenance treatment in the SP515
(NCT00244387) double-blind trial
Exclusion Criteria:
- Subjects who had an ongoing serious adverse event from SP515 (NCT00244387)
double-blind trial that was assessed as related to study medication
Age minimum:
31 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Advanced Stage Parkinson's Disease
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Intervention(s)
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Drug: Rotigotine
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Primary Outcome(s)
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Number of Subjects With at Least One Adverse Event During This Open-label Extension Study
[Time Frame: five years]
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Secondary Outcome(s)
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Number of Subjects Who Withdrew From the Trial Due to an Adverse Event
[Time Frame: five years]
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Mean Epworth Sleepiness Scale Score During the Open-label Extension
[Time Frame: Visit 13 (end of year 1), Visit 17 (end of year 2), Visit 21 (end of year 3), Visit 25(end of year 4)]
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Secondary ID(s)
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SP0516
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2004-000148-26
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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