NCT02227355已完成不适用
A Multi-center Noninterventional Study to Evaluate the Effectiveness of Neupro® (Rotigotine Transdermal Patch) and Levodopa Combination Therapy in Patients With Parkinson's Disease (NEUPART)
UCB Biopharma S.P.R.L.42 个研究点 分布在 5 个国家目标入组 195 人开始时间: 2014年9月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 195
- 试验地点
- 42
- 主要终点
- Change from Baseline to end of the Observational Period in Unified Parkinson's Disease Rating Scale Part II (UPDRS Part II) total score
研究概览
简要总结
This study aims to evaluate the effectiveness of Rotigotine and Levodopa combination therapy for younger and older patients with Parkinson's Disease under real life conditions. Effects on ability to perform activities of daily living, sleep, medication dose and other factors will be assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The following selection criteria must be followed for patients entering the Noninterventional Study (NIS):
- •The decision by the treating physician to prescribe Rotigotine transdermal patch is made before participating in the NIS due to a clinical therapeutic indication (e.g., because of intolerance and/or ineffectiveness of another dopamine agonist)
- •The patient is either male or female and over 18 years of age
- •A Patient Data Consent form is signed and dated by the patient or by the legal representative
- •The patient has idiopathic Parkinson's Disease, has not received Rotigotine within 28 days prior to the Baseline Visit and is willing to participate in questionnaire based assessments
- •The patient is receiving L-dopa as monotherapy or a combination therapy composed of L-dopa and a dopamine agonist other than Rotigotine
- •The patient has been on L-dopa therapy for at least 6 months and is responding to initial L-dopa therapy
- •The patient has a Hoehn and Yahr stage score of 1 to 4.
排除标准
- •Patients will be excluded from the study if they have participated in a clinical study of a medication or a medical device within 3 months prior to Baseline or if they are participating in a clinical study at the time of inclusion or have already participated in the current study.
结局指标
主要结局
Change from Baseline to end of the Observational Period in Unified Parkinson's Disease Rating Scale Part II (UPDRS Part II) total score
时间窗: Baseline to end of Observational Period (6 months)
The UPDRS Part II (Activities of Daily Living) consists of 13 items, each to be scored between 0 (normal/none) and 4 (highest level of severity). The sum score is calculated as the sum of the 13 individual scores (13 questions=52 points maximum; the higher the sum score, the greater degree of disability).
次要结局
- Change from Baseline to end of the Observational Period in L-dopa dose(Baseline to end of Observational Period (6 months))
- Assessment at the end of the Observation Period in the score of the Clinical Global Impressions (CGI) Item 2 (Global Rating of Change of Condition)(End of the Observation Period (Month 6))
- Change from Baseline to end of the Observation Period in Parkinson's Disease Sleep Scale (PDSS-2) total score(Baseline to end of Observational Period (6 months))
- Response at the end of the Observation Period defined as 20 % decrease in Unified Parkinson's Disease Rating Scale Part II (UPDRS Part II) total score(End of the Observation Period (Month 6))
研究者
研究点 (42)
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