Conditions: Parkinson's Disease
Keywords: Parkinson's disease rotigotine patch transdermal dopamine agonist off time Neupro
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 514
Healthy volunteers: no

Brief summary:
The purpose of this study is to show Rotigotine dose response at four doses of Rotigotine used with L-dopa in treating advanced stage Parkinson's disease.

Detailed description:
To maintain treatment blind, two different active patch sizes were used (10 cm\^2 \& 20 cm\^2). Placebo patches matched according to size and appearance. During the trial subjects applied up to three patches, active and placebo, to achieve their assigned daily dose.

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None

Interventions: intervention 1: Rotigotine intervention 2: Rotigotine intervention 3: Placebo intervention 4: Rotigotine intervention 5: Rotigotine
Intervention descriptions: intervention 1: 2 mg/24 hr (one 10 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks intervention 2: 4 mg/24 hr (one 20 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks intervention 3: Placebo transdermal patch applied daily intervention 4: 6 mg/24 hr (one 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks intervention 5: 8 mg/24 hr (two 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks

Protocol document: