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Sponsored by: |
UCB |
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Information provided by: | UCB |
ClinicalTrials.gov Identifier: | NCT00593606 |
This is a Phase 3b, open-label, multicenter trial to assess the safety and tolerability of switching from ropinirole therapy to the rotigotine transdermal system and its effect on symptoms in subjects with idiopathic Parkinson's disease
Condition | Intervention | Phase |
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Parkinson's Disease |
Drug: Rotigotine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 3b, Open-Label, Multicenter Trial to Assess the Safety and Tolerability of Switching Korean Subjects From Ropinirole to the Rotigotine Transdermal System and Its Effect on Symptoms in Idiopathic Parkinson's Disease |
Enrollment: | 124 |
Study Start Date: | July 2007 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Up to 8mg/24h as determined by the investigator
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Drug: Rotigotine
Strength: 2,4,6,and 8mg/24h, form: transdermal application, once daily application
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Subjects are not permitted to enroll in the trial if any of the following criteria are met:
Responsible Party: | UCB ( Study Director ) |
Study ID Numbers: | SP908 |
Study First Received: | December 21, 2007 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00593606 History of Changes |
Health Authority: | Korea: Food and Drug Administration |
Rotigotine NEUPRO Switching trial from ropinirole to rotigotine, safety and tolerability Parkinson disease |
Neurotransmitter Agents Ropinirole 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 Ropinirole Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Basal Ganglia Diseases Nervous System Diseases Central Nervous System Diseases Antiparkinson Agents Dopamine Agonists |
Brain Diseases Neurodegenerative Diseases Pharmacologic Actions Parkinson Disease Movement Disorders Therapeutic Uses Dopamine Agents Parkinsonian Disorders Central Nervous System Agents N 0437 |