Conditions: Idiopathic Parkinson's Disease
Keywords: Rotigotine Neupro® Non-motor symptoms
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 349
Healthy volunteers: no

Brief summary:
The primary objective of this study was to demonstrate that Rotigotine improves non-motor symptoms compared to Placebo in subjects with Parkinson's Disease.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Placebo intervention 2: Rotigotine
Intervention descriptions: intervention 1: Placebo patches of 2, 4, 6 \& 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose was up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose was reached. Maximal dose was 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.

Optimal or maximal dose was maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day. intervention 2: Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours

Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose was up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose was reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.

Optimal or maximal dose was maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.

Protocol document: