Conditions: Idiopathic Parkinson's Disease
Keywords: Rotigotine Neupro®
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 186
Healthy volunteers: no

Brief summary:
The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of rotigotine in subjects with idiopathic PD.

Detailed description:
This is the open-label extension to the open-label trials SP824 (NCT00242008), SP825 (NCT00243971), and SP826 (NCT00243945) that assessed the efficacy and safety and tolerability of rotigotine in subjects with idiopathic Parkinson's Disease.

Arms:
arm 1: Rotigotine

Interventions: intervention 1: Rotigotine
Intervention descriptions: intervention 1: Rotigotine transdermal 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:

The maximum rotigotine dose allowed is 16 mg/24 hours.

Protocol document: