The primary objective of this study is to evaluate the perception of pain associated with Parkinson´s Disease in patients who receive Neupro® for the first time.
Study Type
OBSERVATIONAL
Enrollment
93
61
Feldbach, Austria
60
Linz, Austria
Change From Baseline to Visit 2 in the Sum Score Calculated From the 4 Items of the Affective Dimension of the Pain Description List (Schmerzbeschreibungsliste SBL, Question 10) of the German Pain Questionnaire
The Pain Description List (SBL, question 10) is part of the validated German Pain Questionnaire (DSF). The SBL consists of a 12 item list of adjectives. Each adjective is ranked from 0 (not applicable) to 3 (exactly applicable). 8 of the 12 adjectives will be used to assess the sensory items of pain and 4 adjectives to describe the affective items of pain. The 8 sensory items are used to assess qualitative description of pain. For the 4 affective pain items, a sum score ranges from 0 (not applicable) to 12 (exactly applicable). Values above 8 can be considered noticeable.
Time frame: From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)
Change From Baseline to Visit 2 in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II
The UPDRS is a scale for the assessment of function in Parkinson's disease. Part II measures 'Activities of Daily Living'. It consists of 13 questions, each ranging from 0 (none) to 4 (severe abnormalities). The sum score of the UPDRS Part II ranges from 0 (normal) to 52 (worst score possible).
Time frame: From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)
Change From Baseline to Visit 2 in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part III
The UPDRS is a scale for the assessment of function in Parkinson's disease. Part III measures 'Motor Function'. It consists of 14 items with 27 questions, each ranging from 0 (normal) to 4 (severe abnormalities). The sum score of the UPDRS Part III ranges from 0 (normal) to 108 (worst score possible).
Time frame: From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)
Change From Baseline to Visit 2 in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III
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16
Altenholz, Germany
5
Alzenau in Unterfranken, Germany
22
Bad Honnef, Germany
26
Bad Krozingen, Germany
10
Berlin, Germany
20
Cologne, Germany
4
Dresden, Germany
34
Düsseldorf, Germany
...and 17 more locations
The UPDRS is a scale for the assessment of function in Parkinson's disease. Part II measures 'Activities of Daily Living' and Part III 'Motor Function'. They consist of 40 questions, each ranging from 0 (normal) to 4 (severe abnormalities). The sum score of the UPDRS Part II+III ranges from 0 (normal) to 160 (worst score possible).
Time frame: From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)
Change From Baseline to Visit 2 in the Short-form Parkinson's Disease Questionnaire (PDQ-8) Total Score
The PDQ-8 is a self-administered 8 item questionnaire that assesses the overall health status. The questions will be rated from 0 (never) to 4 (always \[or cannot do at all\]). The total score ranges from 0 (never) to 32 (always \[or cannot do at all\]) with lower scores indicating a better health status.
Time frame: From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)