Conditions: Advanced Idiopathic Parkinson's Disease
Keywords: Parkinson's Disease Rotigotine Chronic Pain Nonmotor symptoms
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 68
Healthy volunteers: no

Brief summary:
This trial is being conducted to compare the impact of Rotigotine and Placebo on Chronic Pain associated with Parkinson's Disease among patients with advanced stages of the disease.

Detailed description:

Arms:
arm 1: Rotigotine Transdermal Patches arm 2: Placebo Transdermal Patches

Interventions: intervention 1: Rotigotine intervention 2: Placebo
Intervention descriptions: intervention 1: Patches will contain 4 mg / 24 h (20 cm\^2), 6 mg/ 24 h (30 cm\^2), or 8 mg /24 h (40 cm\^2) of Rotigotine. Application of study medication starts at the Baseline Visit. Rotigotine will be administered once daily starting at 4 mg / 24 h. Doses will then be up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) is reached and the Maintenance Period can be started. The duration of the Titration Period will vary from 1 to 7 weeks ± 3 days. The Maintenance Period will last 12 weeks ± 5 days. Thereafter, during the De-escalation Period, the dose of study medication will be decreased by 2 mg / 24 h every other day. The De-escalation Period may last up to 12 days. intervention 2: Placebo patches match the size of active patches 20 cm\^2, 30 cm\^2, or 40 cm\^2 and will contain Placebo. Application of Placebo patches starts at the Baseline Visit. Placebo patches will be administered once daily starting with the equivalent of 4 mg / 24 h. Doses will then be up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose is reached. The maximum dose is the equivalent to 16 mg / 24 h. The duration of the Titration Period will vary from 1 to 7 weeks. The Maintenance Period will last 12 weeks ± 5 days. During the De-escalation Period, the dose of Placebo will be decreased by the equivalent to 2 mg / 24 h every other day. The De-escalation Period may last up to 12 days.

Protocol document: