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Sponsored by: |
UCB |
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Information provided by: | UCB |
ClinicalTrials.gov Identifier: | NCT00599196 |
The purpose of this open-label extension is to assess the safety and tolerability of long-term treatment of rotigotine in subjects with idiopathic Parkinson's disease.
Condition | Intervention | Phase |
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Early Stage, Idiopathic Parkinson's Disease |
Drug: Rotigotine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety Study |
Official Title: | An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine CDS in Subjects With Early Stage, Idiopathic Parkinson's Disease(Part II of Double Blind SP513). |
Enrollment: | 381 |
Study Start Date: | November 2002 |
Study Completion Date: | December 2008 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Active treatment with rotigotine, dose adjustment as required.
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Drug: Rotigotine
Transdermal patches (Sizes 10, 20, 30 and/or 40cm2) 2mg/24h, 4mg/24h, 6mg/24h, 8mg/24h, 12mg/24h, 16mg/24h once daily, 24 hours
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Ages Eligible for Study: | 30 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
Responsible Party: | UCB ( Study Director ) |
Study ID Numbers: | SP716 |
Study First Received: | December 24, 2007 |
Last Updated: | January 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00599196 History of Changes |
Health Authority: | Austria: Agency for Health and Food Safety; Australia: Department of Health and Ageing Therapeutic Goods Administration; Croatia: Ministry of Science, Education and Sports; Belgium: Directorate general for the protection of Public health: Medicines; Czech Republic: State Institute for Drug Control; France: Afssaps - French Health Products Safety Agency; Finland: National Agency for Medicines; Hungary: National Institute of Pharmacy; Israel: Ministry of Health; Netherlands: Medicines Evaluation Board (MEB); New Zealand: Health Research Council; Norway: Norwegian Medicines Agency; Poland: Ministry of Health; South Africa: Department of Health; Sweden: Medical Products Agency; Switzerland: Swissmedic; Italy: Ministry of Health; Spain: Comité Ético de Investigación Clínica; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Rotigotine NEUPRO |
Neurotransmitter Agents Ganglion Cysts Basal Ganglia Diseases Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases Dopamine Agonists |
Dopamine Parkinson Disease Movement Disorders Dopamine Agents Parkinsonian Disorders N 0437 |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Basal Ganglia Diseases Nervous System Diseases Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases |
Dopamine Agonists Pharmacologic Actions Parkinson Disease Movement Disorders Dopamine Agents Parkinsonian Disorders N 0437 |