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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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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2004-000148-26-IT |
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Date of registration:
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26/07/2007 |
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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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A multi-center, multinational, phase 3, open-label extension trial to assess the safety of long term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinsons disease who are not well controlled on levodopa
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Scientific title:
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A multi-center, multinational, phase 3, open-label extension trial to assess the safety of long term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinsons disease who are not well controlled on levodopa |
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Date of first enrolment:
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14/06/2004 |
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Target sample size:
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360 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-000148-26 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: yes
Other: no
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Phase:
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Countries of recruitment
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Czech Republic
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Finland
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Hungary
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Italy
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Spain
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Sweden
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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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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Pharmaceutical Form: Transdermal patch
INN or Proposed INN: rotigotine
Current Sponsor code: SPM962
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4.5-
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Primary Outcome(s)
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Primary end point(s):
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Main Objective:
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Secondary Objective:
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Secondary ID(s)
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2004-000148-26-FI
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SP516
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Source(s) of Monetary Support
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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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