Conditions: Idiopathic Parkinson's Disease
Keywords: Rotigotine Neupro phase 3 Advanced-stage Idiopathic Parkinson's Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 346
Healthy volunteers: no

Brief summary:
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.

Detailed description:
The study included a maximum 4-week Screening Period, a maximum 7-week Titration Period for advanced-stage Parkinson's disease, 12-week Maintenance Period, a maximum 12-day De-escalation Period for advanced-stage Parkinson's Disease and 30-day Safety Follow-Up Period. The maximum study duration for an individual subject with advanced-stage Parkinson's disease was 27 weeks.

Arms:
arm 1: Rotigotine, daily doses, treatment group arm 2: Placebo, daily doses, placebo group

Interventions: intervention 1: Rotigotine intervention 2: Placebo Patch intervention 3: L-dopa
Intervention descriptions: intervention 1: Transdermal Patch

Content:

4 mg /24 h (20 cm\^2), 6 mg /24 h (30 cm\^2), 8 mg /24 h (40 cm\^2)

For advanced-stage Parkinson's Disease, subjects received Rotigotine patches in escalating weekly dose (starting with daily doses 4 mg/24 h to 16 mg/24 h) for a maximum 7-week Titration Period, then 12 week maintenance period intervention 2: Transdermal Patch

Size:

20 cm\^2, 30 cm\^2, 40 cm\^2

Subjects randomized to placebo received matching placebo patches intervention 3: Subject must be on a stable dose of L-dopa (either short-acting or sustained release \[in combination with benserazide or carbidopa\]) of at least 200 mg/day, administered in at least 2 intakes, for at least 28 days prior to Baseline.

Protocol document: