Conditions: IDIOPATHIC PARKINSON'S DISEASE
Keywords: Rotigotine Neupro phase 3 Early phase Idiopathic Parkinson's Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 249
Healthy volunteers: no

Brief summary:
The primary objective is to demonstrate that the Rotigotine transdermal patch is efficacious in Chinese subjects with early-stage idiopathic Parkinson's disease.

Detailed description:
The study includes a maximum 4-week Screening Period, a maximum 4-week Titration Period for early-stage Parkinson's disease 24-week Maintenance Period, a maximum 6-day De-escalation Period and 30-day Safety Follow-Up Period. The maximum study durations for an individual subject with early-stage Parkinson's disease will be 36 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 descriptions: intervention 1: Transdermal Patch

Content:

2 mg /24 h (10 cm\^2), 4 mg /24 h (20 cm\^2), 6 mg /24 h (30 cm\^2), 8 mg /24 h (40 cm\^2)

For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period intervention 2: Transdermal Patch

Size:

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

Subjects randomized to placebo will receive matching placebo patches

Protocol document: