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Sponsored by: |
UCB |
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Information provided by: | UCB |
ClinicalTrials.gov Identifier: | NCT00594165 |
The purpose of this study is to show that rotigotine patch is effective and safe for the long-term treatment of subjects with early stage Parkinson's disease.
Condition | Intervention | Phase |
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Parkinson's Disease |
Drug: Rotigotine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label Extension to Assess the Safety of Long-Term Treatment of Rotigotine CDS |
Enrollment: | 217 |
Study Start Date: | June 2002 |
Study Completion Date: | November 2008 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
The subjects dose of rotigotine may be increased, or decreased, as needed to maintain a subject's effective dose during the study.
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Drug: Rotigotine
10cm2 (2mg); 20cm2 (4mg); 30cm2 (6mg) and/or 40cm2 (8mg) transdermal patch Optimal dosing: During the first year: The maximum rotigotine dose allowed is 13.5 mg (30cm2) per day. After the first year: Subjects may benefit from a dose increase of rotigotine up to 36.0 mg (80 cm2) per day. |
The objective 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.
Ages Eligible for Study: | 31 Years and older |
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: | SP702 |
Study First Received: | December 24, 2007 |
Last Updated: | January 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00594165 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Rotigotine Open label extension study Neupro |
Dopamine Ganglion Cysts Movement Disorders Parkinson Disease Basal Ganglia Diseases |
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Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Nervous System Diseases |
Dopamine Agents Dopamine Agonists Pharmacologic Actions |