Conditions: Advanced Idiopathic Parkinson's Disease
Keywords: Rotigotine Neupro Switch Dopamine agonists
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 87
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess the safety and feasibility of switching subjects with advanced Parkinson's Disease (PD) from Pramipexole or Ropinirole to Rotigotine and to assess the effects of Rotigotine on motor and non-motor symptoms of Parkinson's Disease in subjects switched from previous treatment with either Pramipexole or Ropinirole.

Detailed description:

Arms:
arm 1: First application of Rotigotine patch for 24 hours on Day 1, followed by application of a new patch each day of the Treatment Period.

* Subjects on lower doses switch from Pramipexole or Ropinirole to equivalence doses of Rotigotine on Day 1 of the 28 days Treatment Period. On Day 8 (Visit 3) the dose will be evaluated and potentially adjusted up to a maximum dose of 8 mg / 24 hours.
* Subjects on higher doses switch from the equivalent dose to 8 mg / 24 hours Rotigotine of Pramipexole or Ropinirole to 8 mg / 24 hours Rotigotine on Day 1 and the remainder of the dose of Pramipexole or Ropinirole is to be switched on Day 8 of the 28 days Treatment Period. On Day 15 (Visit 4) the dose will be evaluated and potentially adjusted up to a maximum dose of 16 mg / 24 hours.

Interventions: intervention 1: Rotigotine
Intervention descriptions: intervention 1: Rotigotine up to 16 mg / 24 hours, 4 weeks.

Protocol document: