A Phase 4, Open-label Study to Assess the Feasibility and Efficacy on Motor and Non-motor Symptoms of Switching From Pramipexole or Ropinirole to Rotigotine Transdermal Patch in Subjects With Advanced Idiopathic Parkinson's Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01711866|
Recruitment Status : Completed
First Posted : October 22, 2012
Results First Posted : April 7, 2014
Last Update Posted : April 7, 2014
|Condition or disease||Intervention/treatment||Phase|
|Advanced Idiopathic Parkinson's Disease||Drug: Rotigotine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||87 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
First application of Rotigotine patch for 24 hours on Day 1, followed by application of a new patch each day of the Treatment Period.
Rotigotine up to 16 mg / 24 hours, 4 weeks.
Other Name: Neupro
- Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period or Early Withdrawal Visit [ Time Frame: 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.
- Patients Global Impressions of Change (PGIC) at the End of the Treatment Period or Early Withdrawal Visit [ Time Frame: Day 28 (Visit 5) of the 28 days 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01711866
|Study Director:||UCB Clinical Trial Call Center||+1 877 822 9493 (UCB)|