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An Open-Label, Multicenter, Multinational Study to Assess the Feasibility of Switching Therapy From Pramipexole or Ropinirole to the Rotigotine Transdermal System and Its Effect on Motor and Non-Motor Symptoms in Subjects With Advanced Idiopathic Parkinson's Disease Phase 4
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.
Details
| Lead sponsor | UCB BIOSCIENCES GmbH |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 87 |
| Start date | 2012-09 |
| Completion | 2013-03 |
Conditions
- Advanced Idiopathic Parkinson's Disease
Interventions
- Rotigotine
Primary outcomes
- Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period or Early Withdrawal Visit — Day 28 (Visit 5) of the 28 days 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.
Countries
United States, Malaysia, Singapore, South Korea, Taiwan