NCT02906488已完成不适用
Special Drug Use Results Survey of Safety and Efficacy of Long-term (104 Weeks) Use of Duodopa Enteral Solution in Patients With Parkinson's Disease in Actual Usage Condition
AbbVie127 个研究点 分布在 1 个国家目标入组 839 人开始时间: 2016年9月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 839
- 试验地点
- 127
- 主要终点
- Change in "Off" Periods From Start of Treatment to Week 104
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of long-term use of Duodopa in patients with Parkinkon's disease in actual usage
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Parkinson's disease using Duodopa for the purpose of improving circadian change (wearing-off phenomenon) of symptoms of Parkinson's disease in which sufficient effect cannot be obtained with existing drug therapy including levodopa-containing drugs.
排除标准
- 未提供
结局指标
主要结局
Change in "Off" Periods From Start of Treatment to Week 104
时间窗: 104 weeks
"Off" periods describe those times when medication is not working well and a person has greater difficulty with movement.
次要结局
- Time-dependent Change in Parkinson's Disease Questionnaire - 8 Items (PDQ-8)(104 weeks)
- "Off" Period and "On" Period Accompanied by Dyskenesia Interfering with Daily Activities by Patient Characteristic Factor(104 weeks)
- Time-dependent Change in Unified Parkinson's Disease Rating Scale (UPDRS)(104 Weeks)
- Time-dependent Change in "Off" Time and "On" Time Accompanied By Dyskinesia Interfering with Daily Activities(104 Weeks)
- Time-dependent Change in Parkinson's Disease Quality of Life Questionnaire - Carers (PDQ-Carer)(104 weeks)
研究者
研究点 (127)
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