An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's Disease
NCT ID: NCT00599196
Last Updated: 2014-10-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
381 participants
INTERVENTIONAL
2002-08-31
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Rotigotine
Rotigotine
Rotigotine
Rotigotine trans-dermal patches, once daily:
10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours); 50 cm2 (10 mg/24 hours); 60 cm2 (12 mg/24 hours); 70 cm2 (14 mg/24 hours); 80 cm2 (16 mg/24 hours);
Optimal dosing:
During the first year: The maximum Rotigotine dose allowed is 8 mg/24 hours.
After the first year: allowed dose increase of rotigotine up to a maximum of 16 mg/24 hours.
Interventions
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Rotigotine
Rotigotine trans-dermal patches, once daily:
10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours); 50 cm2 (10 mg/24 hours); 60 cm2 (12 mg/24 hours); 70 cm2 (14 mg/24 hours); 80 cm2 (16 mg/24 hours);
Optimal dosing:
During the first year: The maximum Rotigotine dose allowed is 8 mg/24 hours.
After the first year: allowed dose increase of rotigotine up to a maximum of 16 mg/24 hours.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
30 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
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Concord, , Australia
Darlinghurst, , Australia
East Gosford, , Australia
Westmead, , Australia
Innsbruck, , Austria
Vienna, , Austria
Brussels, , Belgium
Hoboken, , Belgium
Zagreb, , Croatia
Brno, , Czechia
Ostrava, , Czechia
Pilsen, , Czechia
Espoo, , Finland
Kuopio, , Finland
Lappeenranta, , Finland
Oulu, , Finland
Pori, , Finland
Aix-en-Provence, , France
Caen, , France
Toulouse, , France
Aachen, , Germany
Dresden, , Germany
Kiel, , Germany
Marburg, , Germany
Budapest, , Hungary
Miskolc, , Hungary
Pécs, , Hungary
Hadera, , Israel
Petah Tikva, , Israel
Tel Aviv, , Israel
Milan, , Italy
Padua, , Italy
Pozzilli, , Italy
Breda, , Netherlands
Geldrop, , Netherlands
Auckland, , New Zealand
Christchurch, , New Zealand
North Shore, , New Zealand
Wellington, , New Zealand
Stavanger, , Norway
Trondheim, , Norway
Gdansk, , Poland
Katowice, , Poland
Krakόw, , Poland
Lublin, , Poland
Mosina k/Poznania, , Poland
Olsztyn, , Poland
Warsaw, , Poland
Cape Town, , South Africa
Pretoria, , South Africa
Barcelona, , Spain
Pamplona, , Spain
Karlstad, , Sweden
Stockholm, , Sweden
Bern, , Switzerland
Lausanne, , Switzerland
Birmingham, , United Kingdom
Blackpool, , United Kingdom
Glasgow, , United Kingdom
Liverpool, , United Kingdom
London, , United Kingdom
Newcastle upon Tyne, , United Kingdom
Swansea, , United Kingdom
Countries
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References
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Giladi N, Boroojerdi B, Surmann E. The safety and tolerability of rotigotine transdermal system over a 6-year period in patients with early-stage Parkinson's disease. J Neural Transm (Vienna). 2013 Sep;120(9):1321-9. doi: 10.1007/s00702-013-1001-5. Epub 2013 Mar 19.
Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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SP513OL
Identifier Type: OTHER
Identifier Source: secondary_id
SP0716
Identifier Type: -
Identifier Source: org_study_id
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