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Sponsored by: |
UCB |
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Information provided by: | UCB |
ClinicalTrials.gov Identifier: | NCT00292227 |
Rotigotine (SPM 962) transdermal patch is in development for early- and advanced-stage Parkinson's disease (patch sizes/doses of up to 40 cm2/18.0 mg/day and 80 cm2/36.0 mg/day, respectively) and for restless legs syndrome (up to 15 cm2/6.75 mg/day). During development, electrocardiographic data were collected in subjects treated with rotigotine in doses up to 36.0 mg/day. These evaluations provided no indication for drug-induced prolongation of QT/QTc interval by rotigotine in the target population. Schwarz will conduct a thorough QT/QTc trial according to current regulatory guidelines. This trial investigates potential electrocardiographic effects of rotigotine in doses up to 120 cm2/54.0 mg/day (reflecting supratherapeutic doses for the advanced-stage Parkinson´s disease indication) in a double-blind, randomized, placebo- and positive-controlled thorough QT/QTc trial in subjects with advanced-stage idiopathic Parkinson's disease.
Condition | Intervention | Phase |
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Parkinson's Disease |
Drug: SPM-962 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Double-Blind, Randomized, Placebo- and Positive-Controlled, Parallel-Group Trial to Assess the Potential Electrocardiographic Effects of Rotigotine Transdermal System up to 120 cm2/54.0 mg/Day in Subjects With Advanced-Stage Idiopathic Parkinson's Disease: A "Thorough" QT/QTc Trial |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: - Advanced-stage idiopathic Parkinson's disease
Study ID Numbers: | SP864 |
Study First Received: | February 14, 2006 |
Last Updated: | March 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00292227 History of Changes |
Health Authority: | United States: Food and Drug Administration |
advanced-stage idiopathic Parkinson's disease |
Ganglion Cysts Arnold-Chiari Malformation Movement Disorders Parkinson Disease Basal Ganglia Diseases |
Central Nervous System Diseases Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases |
Movement Disorders Parkinson Disease Nervous System Diseases Basal Ganglia Diseases |
Central Nervous System Diseases Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases |