Conditions: Advanced Parkinson's Disease
Keywords: Rotigotine Neupro
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 90
Healthy volunteers: no

Brief summary:
This study is to investigate the safety and efficacy of Rotigotine add-on therapy with low doses of Pramipexole or Ropinirole in patients with advanced-stage Parkinson's Disease (PD) who have insufficient response to L-dopa and low doses dopamine receptor agonists.

Detailed description:

Arms:
arm 1: \- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.

Duration of the Titration Period: Between 1 week and 5 weeks.

\- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.

Duration of the Maintenance Period: Between 3 weeks and 7 weeks.

Interventions: intervention 1: Rotigotine
Intervention descriptions: intervention 1: Application of Rotigotine up to 8 mg/24 h patches for 24 hours.

Protocol document: