NCT02073981已完成不适用
Japan-First-in Large Scale Observational Study for Non-motor Symptoms and Treatment in Parkinson's Disease Patients.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,021
- 试验地点
- 1
- 主要终点
- Changing of Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
研究概览
简要总结
This study is implemented to identify factors having an impact on improvement or exacerbation of non-motor symptoms, to provide information contributing to development of medical care in this field and improvement of patients' QOL, and to clarify the association between the use of istradefylline and non-motor symptoms or QOL.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have wearing off under treatment with levodopa-containing drugs administered at least three times daily
- •Patients who have at least one non-motor symptom as a complication
- •Patients at least 20 years of age at the time of consent
- •Patients who have given written consent
- •Patients who are receiving outpatient care
排除标准
- •Patients with dementia or a score of 23 or less on the Mini-Mental State Examination (MMSE)
- •Patients, in the opinion of the investigator or subinvestigator, having conditions impairing the proper assessment of the MDS-UPDRS or PDQ-8 (e.g., patients who are receiving treatment for malignant tumor)
结局指标
主要结局
Changing of Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
时间窗: 52 weeks
MDS-UPDRS score will be collected from all registrant at each visit and on the last day of survey.
Changing of Parkinson's Disease Questionaire-8 (PDQ-8) score.
时间窗: 52 weeks
PDQ-8 score will be collected from all registrant at each visit and on the last day of survey.
次要结局
未报告次要终点
研究者
研究点 (1)
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