A Multicenter, Non-interventional Study With Neupro® to Evaluate the Perception of Pain Associated With Idiopathic Parkinson's Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Idiopathic Parkinson's Disease
- Sponsor
- UCB Pharma GmbH
- Enrollment
- 93
- Locations
- 27
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The decision by the treating physician to treat a patient with Neupro® for the first time is made before the patient's participation in this Non-Interventional Study (NIS)
- •A Patient Data Consent form is signed and dated by the patient
- •Male and female patients that suffer from pain associated with idiopathic Parkinson's Disease according to the physician's assessment
- •Patients have not been treated with Rotigotine in the past
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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
Time Frame: From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)
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.
Secondary Outcomes
- Change From Baseline to Visit 2 in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III(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(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(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(From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®))