Canadian Advanced Parkinson DUODOPA-Treated Patients Observational Study Evaluating Long-Term Health Outcomes in Centers of Excellence (CADENCE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 13
- 主要终点
- Change in participant's motor symptoms
研究概览
简要总结
This is an open-label, postmarketing, observational study to document health outcomes, in Canadian patients with advanced Parkinson's disease and long-term treatment with Duodopa (levodopa/carbidopa intestinal gel).
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
- •Diagnosed with advanced Parkinson's Disease
- •Prescribed Duodopa by his/her treating physician.
排除标准
- •Patients who were previously treated with Duodopa.
- •Presence of other condition that, in the opinion of the treating physician, prohibits the patient from participating in the study or obscures the assessment of the treatment of advanced PD.
结局指标
主要结局
Change in participant's motor symptoms
时间窗: Baseline, Day 1, Month 3, Month 6, and every 6 months thereafter up to 48 months
Evaluated via the Unified Parkinson's Disease Rating Scale (UPDRS) Part II, III, V and Part IV items 33-35; items 32 \& 39 modified as per MDS-UPDRS, and the Freezing of Gait Questionnaire (FOGQ).
Change in the Parkinson's Disease Questionnaire (PDQ-39)
时间窗: Baseline, Day 1, Month 3, and every 6 months thereafter up to 48 months
Evaluated via the Parkinson's Disease Questionnaire (PDQ-39)
Change in caregiver burden
时间窗: Baseline, Day 1, Month 3, and every 6 months thereafter up to 48 months
Evaluated via the Zarit Care Giver Burden Questionnaire.
Change in the non-motor symptoms.
时间窗: Baseline, Day 1, Month 3, and very 6 months thereafter up to 48 months
Evaluated via the Non-Motor symptoms Scale (NMS) and the Parkinson's Disease Sleep Scale (PDSS-2).
Change in the cognitive functions.
时间窗: Baseline, Day 1, and every 12 months thereafter up to 48 months
Evaluated via the Montreal Cognitive Assessment (MoCa).
Change in caregiver work productivity
时间窗: Baseline, Day 1, Month 3, and every 6 months thereafter up to 48 months
Evaluated by the Work Productivity and Activity Information Questionnaire (WPAI - care giver)
Change in the participant's Healthcare Resource Utilization
时间窗: Baseline, Month 3, and every 6 months thereafter up to 48 months
Evaluated via the Health Care Resources Utilization Questionnaire (HCRU).
次要结局
未报告次要终点