A Multinational, Multicentre, Prospective Non-interventional Study to Assess Safety and Effectiveness of Opicapone Plus Standard of Care in Elderly Patients With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Percentage of patients having at least one Adverse Event (AE)
研究概览
简要总结
The purpose of this study is to describe the safety and efficacy of opicapone plus standard of care in elderly patients with PD in the real-world setting
详细描述
This will be a multinational, multicentre, prospective non-interventional study in elderly patients with PD. Approximately 100 patients with PD will be recruited by specialists from approximately 37 sites in European countries. The total enrolment period will be one year, and each patient will be followed for up to one year after enrolment.
PD patients with end-of-dose motor fluctuations suitable for additional treatment optimization will be included in the study and split into 2 cohorts:
- Cohort 1: 50 patients; standard of care (including L-DOPA) + starting opicapone
- Cohort 2: 50 patients; standard of care (including L-DOPA Data will be collected at baseline (date of enrolment), 1 month, 3 months, 6 months, 9 months, and 12 months after enrolment.
This non-interventional study does not recommend the use of any specific treatments. Use of opicapone and of standard of care are only driven by the physician's decision.
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
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient or legally acceptable representative willing and able to provide informed consent as mandated by local regulation
- •Patient with clinical diagnosis of idiopathic PD (excluding non-idiopathic PD: atypical Parkinsonism, secondary [acquired or symptomatic] Parkinsonism, Parkinson-plus syndrome)
- •Patient with age >=75 years at enrolment
- •Patient with end-of-dose motor fluctuations suitable for additional treatment optimization
排除标准
- •Patient concurrently participating in any clinical trial
- •Patient who used tolcapone or opicapone previously
- •For the patient who starts opicapone: concomitant treatment with entacapone or tolcapone is not allowed
- •Patient with any contraindications to Ongentys use
- •Patient with any concomitant medical condition that could interfere with study assessments
研究组 & 干预措施
Cohort 1
Standard of care (including L-DOPA) + starting opicapone
干预措施: Opicapone (Drug)
Cohort 1
Standard of care (including L-DOPA) + starting opicapone
干预措施: Levodopa (L-DOPA) + Standard care (Drug)
Cohort 2
Standard of care (including L-DOPA)
干预措施: Levodopa (L-DOPA) + Standard care (Drug)
结局指标
主要结局
Percentage of patients having at least one Adverse Event (AE)
时间窗: through study completion, an average of 1 year
All AEs reporting
次要结局
- Unified Parkinson's Disease Rating Scale (UPDRS)(at baseline, Follow-up visit at 6,12 months)
- Patients' Global Impressions of Change (PGI-C)(at Follow-up visit at 1, 3, 6, 9, 12 months)
- Parkinson Disease Questionnaire (PDQ-8)(at baseline, Follow-up visit at 6,12 months)
- Clinical Global Impression of Improvement (CGI-I)(at Follow-up visit at 1, 3, 6, 9, 12 months)
- Montreal Cognitive Assessment (MoCA)(at baseline, Follow-up visit at 6,12 months)