Conditions: Early-Stage Parkinson's Disease
Keywords: Rotigotine
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 217
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-controlled SP512 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:

10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours)

Optimal dosing:

During the first year:

The maximum Rotigotine dose allowed is 6 mg/24 hours.

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

Protocol document: