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A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of The Efficacy And Safety of Rotigotine Transdermal Patch In Chinese Subjects With Advanced-stage, Idiopathic Parkinson's Disease Who Are Not Well Controlled On Levodopa
The primary objective of this study was to demonstrate that Rotigotine transdermal patch is efficacious in Chinese subjects with advanced-stage Idiopathic Parkinson's Disease as an adjuvant therapy.
Details
| Lead sponsor | UCB Pharma |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 346 |
| Start date | 2012-07 |
| Completion | 2014-10 |
Conditions
- Idiopathic Parkinson's Disease
Interventions
- Rotigotine
- Placebo Patch
- L-dopa
Primary outcomes
- Absolute Change in Absolute Time Spent 'Off' From Baseline to the End of Double-blind Maintenance Period — From Baseline (Week 0) to end of Maintenance Period (up to Week 12)
A subject has been considered "off" when he/she began to lose the optimum effects of anti-Parkinson's medication. A negative mean indicates a reduction of the time off during the conduct of the study
Countries
China