Conditions: Idiopathic Parkinson's Disease
Keywords: Parkinson's Disease Rotigotine Apathy Nonmotor Motor Neupro
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 122
Healthy volunteers: no

Brief summary:
This trial is being conducted to assess the effects of Rotigotine over Placebo on improvement of Apathy and motor symptoms in subjects with early-stage and advanced stage idiopathic Parkinson´s Disease.

Detailed description:

Arms:
arm 1: Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease arm 2: Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease arm 3: Placebo transdermal patches

Interventions: intervention 1: Rotigotine intervention 2: Placebo
Intervention descriptions: intervention 1: Rotigotine, transdermal patches:

10 cm\^2 (2 mg / 24 hours); 20 cm\^2 (4 mg / 24 hours); 30 cm\^2 (6 mg / 24 hours); 40 cm\^2 (8 mg / 24 hours)

The maximum Rotigotine dose allowed is 8 mg / 24 hours or 16 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours or 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation) intervention 2: Placebo, matching transdermal patches

Duration: up to 21 weeks (including de-escalation)

Protocol document: