A Multicenter, Non-interventional Study With Neupro® to Evaluate the Perception of Pain Associated With Idiopathic Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 27
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
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
时间窗: 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.
次要结局
- 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®))