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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
87
Rotigotine up to 16 mg / 24 hours, 4 weeks.
505
Anniston, Alabama, United States
506
Atlantis, Florida, United States
508
Miami Springs, Florida, United States
502
Atlanta, Georgia, United States
501
Dayton, Ohio, United States
509
Oklahoma City, Oklahoma, United States
202
Sarawak, Malaysia
401
Singapore, Singapore
403
Singapore, Singapore
101
Busan, South Korea
...and 11 more locations
Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period or Early Withdrawal Visit
The CGI Item 4 was used to assess side effects. It ranges from 0 to 4 as follows: * 0 = Side effects not assessable * 1 = No side effects * 2 = Side effects do not significantly interfere with subject's functioning * 3 = Side effects significantly interfere with the subject's functioning * 4 = Side effects outweigh therapeutic efficacy.
Time frame: Day 28 (Visit 5) of the 28 days Treatment Period or Early Withdrawal Visit
Patients Global Impressions of Change (PGIC) at the End of the Treatment Period or Early Withdrawal Visit
The PGIC is a 7-point categorical rating scale in which the subject rates the changes in functioning over time as follows: * 1 = Very much improved * 2 = Much improved * 3 = Minimally improved * 4 = No change * 5 = Minimally worse * 6 = Much worse * 7 = Very much worse.
Time frame: Day 28 (Visit 5) of the 28 days Treatment Period or Early Withdrawal Visit
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