Conditions: Advanced Stage Parkinson's Disease
Keywords: Rotigotine Neupro®
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 395
Healthy volunteers: no

Brief summary:
The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of the rotigotine patch in subjects with advanced-stage idiopathic Parkinson's disease

Detailed description:
This is the open-label extension to the randomized, double-blind, placebo-and active controlled SP515 (NCT00244387) trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with advanced-stage idiopathic Parkinson's Disease that were not well-controlled on levodopa

Arms:
arm 1: Rotigotine

Interventions: intervention 1: Rotigotine
Intervention descriptions: intervention 1: Rotigotine trans-dermal patches once daily:

20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours) 50 cm2 (10 mg/24 hours) 60 cm2 (12 mg/24 hours) 70 cm2 (14 mg/24 hours) 80 cm2 (16 mg/24 hours)

Protocol document: