NCT01504529已完成不适用
Non-Interventional, Retrospective, Multi-center Study to Evaluate Non-Motor Symptoms in Advanced PD Patients Already Treated With Rotigotine
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 391
- 试验地点
- 59
- 主要终点
- Change from Baseline to Month 6 in Non-Motor Symptoms (NMS) as assessed by the Parkinson's Disease Non-Motor Symptoms Questionnaire (PDNMS-Q)
研究概览
简要总结
This is an observational, non-interventional and retrospective study in patients with advanced PD who have been treated with Rotigotine (Neupro®) as prescribed by physicians according to usual clinical practice in Spain.
The Primary Objective will be to evaluate Non-Motor Symptoms (NMS) in advanced PD patients who have been treated with Rotigotine for at least 6 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible to participate in this study, all of the following criteria must be met:
- •Male and female ambulatory patients with Parkinson's disease diagnosis (as per the London Brain Bank diagnosis criteria) ≥6 months ago
- •Patient aged 30 years or older at the time of Parkinson's disease diagnosis
- •Patients who were under treatment with Rotigotine following routine clinical practice, either alone or in combination with Levodopa, and in an advanced PD dosage (≥ 8 mg/ 24 h) for at least the previous 6 months
- •Patients under treatment with Rotigotine (≥ 8 mg/ 24 h) who were assessed twice of NMS by means of the PDNMS-Q 6 months apart
- •Patients are currently informed and have been given enough time and opportunity to think about participation (data collection) in the study and have given written informed consent
排除标准
- •Patients are not permitted to enroll in the study if any of the following criteria is met during the previous 6 months:
- •Patients have other Parkinsonian syndrome different than Parkinson´s disease
- •Patients have a history of Pallidotomy, Thalamotomy, Deep Brain Stimulation or Fetal Tissue Transplant
- •Patients with Dementia, active Hallucinations or active or treated Psychosis
- •Patients with any other neurological / psychological disorder
- •Patients who had received Central Nervous System (CNS) active therapy (e.g. sedatives, hypnotics, anti-depressants, anxiolytics, atypical neuroleptics, etc)
结局指标
主要结局
Change from Baseline to Month 6 in Non-Motor Symptoms (NMS) as assessed by the Parkinson's Disease Non-Motor Symptoms Questionnaire (PDNMS-Q)
时间窗: From Baseline to Month 6
次要结局
- Change from Baseline to Month 6 in Unified Parkinson's Disease Rating Scale (UPDRS) Part III(From Baseline to Month 6)
- Change from Baseline to Month 6 in Hoehn & Yahr stage(From Baseline to Month 6)
研究者
研究点 (59)
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