The primary purpose is to demonstrate superiority of Rotigotine over Placebo on motor symptoms when used in subjects with symptoms of Gastrointestinal Dysfunction. Hypothesis: Rotigotine will decrease OFF time compared to Placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
25
Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours Dosage and Frequency: One patch every 24 hours Duration: 10 weeks
Frequency: One patch applied every 24 hours Duration: 10 weeks
011
Birmingham, Alabama, United States
001
Gilbert, Arizona, United States
Change in Rotigotine Versus Placebo in the Absolute Time Spent "Off" From Baseline to the End of the 7-week Maintenance Period
Mean number of hours marked "off" during a 24-hour period.
Time frame: Baseline to 10 weeks
Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS UPDRS) Part III (Motor Examination) in the "on" State From Baseline to the End of the 7-week Maintenance Period
The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS UPDRS) Part III is an 18-item scale with each single item of the scale ranging from 0 (normal) to 4 (severe).
Time frame: Baseline to 10 weeks
Change in Predictability of "Off" Time (Using MDS UPDRS Part IV Item 4.5) From Baseline to End of the 7-week Maintenance Period
The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS UPDRS) Part IV is a 6-item scale with each single item of the scale ranging from 0 (normal) to 4 (severe).
Time frame: Baseline to 10 weeks
Change in Score on Gastrointestinal Neurodegenerative Scale (GIND) From Baseline to the End of the of the 7-week Maintenance Period
Gastrointestinal Neurodegenerative Scale (GIND) is an 18-item scale measuring gastrointestinal dysfunction with each single item of the scale ranging from 0 (never or not at all) to 5 (very severe).
Time frame: Baseline to 10 weeks
Change in Score on Fatigue Severity Scale (FSS) From Baseline to the End of 7-week Maintenance Period
The Fatigue Severity Scale is a 9-item scale measuring the impact of fatigue on everyday functioning (e.g. "fatigue interferes with my work, each single item of the scale ranging from 1 (disagree) to 7 (agree).
Time frame: Baseline to 10 weeks
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022
Fountain Valley, California, United States
017
Irvine, California, United States
028
Pasadena, California, United States
015
Sunnyvale, California, United States
008
Gainesville, Florida, United States
009
Miami, Florida, United States
010
Ormond Beach, Florida, United States
006
Sunrise, Florida, United States
...and 16 more locations
Change in Score on Parkinson's Disease Questionnaire (PDQ8) From Baseline to the End of 7-week Maintenance Period
The Parkinson's Disease Questionnaire (PDQ-8) is a self-administered 8-item questionnaire that assesses issues associated with Parkinson's disease. Each single item of the 8-item questionnaire ranges from 0 (never) to 4 (always).
Time frame: Baseline to 10 weeks