Conditions: Early Stage Parkinson's Disease
Keywords: Rotigotine Neupro®
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 381
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 early-stage idiopathic Parkinson's disease

Detailed description:
This is the open-label extension to the randomized, double-blind, placebo- and ropinirole-controlled SP513 trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with early-stage idiopathic Parkinson's Disease

Arms:
arm 1: Rotigotine

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

10 cm2 (2 mg/24 hours); 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);

Optimal dosing:

During the first year: The maximum Rotigotine dose allowed is 8 mg/24 hours.

After the first year: allowed dose increase of rotigotine up to a maximum of 16 mg/24 hours.

Protocol document: