Real-life, Observational Study on Opicapone in Patients With Parkinson's Disease and Early Motor Fluctuations in Italy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 20
- 主要终点
- Patient Global Impression of Change (PGI-C) score improvement (minimally, much or very much), no change or worsening (minimally, much or very much) 12 months after start of treatment.
研究概览
简要总结
The present study aims to evaluate the effectiveness and safety of opicapone in a real-world setting at centers for Parkinson's disease located in Italy.
详细描述
This is a multicenter, prospective, observational cohort study of patients with Parkinson's Disease and early motor fluctuations treated with opicapone in Italy.
Treatment with opicapone will be independent from participation in this observational study and must not be initiated for the purpose of participating in it. Opicapone will be administered according to the local Summary of Product Characteristics (SmPC).
Data on patients will be collected in accordance with routine clinical visits and examinations starting from the date when patient consent is obtained, and for up to two years after start of treatment with opicapone. The collection of the patient-reported outcomes (PRO) and clinician-reported outcomes (ClinRO) will be dictated by the routine clinical practice at each center; thus, scales left blank will not be considered protocol deviations.
Patients will be followed up for a maximum of 2 years (±2 months). Because of the observational design of the study, there are no imposed visits beyond those performed as per clinical practice. Visits are however planned closest to 6 months (±2 months), 12 months (±2 months), 18 months (±2 months), and 24 months (±2 months) after inclusion.
The overall duration of the study will be of approximately 5 years, with 24 months of recruitment and 24 months (±2 months) of follow-up from the last patient in. The End of Study (EOS) is defined as the time when the last enrolled patient has completed 24 months (±2 months) of assessments (unless early termination) after enrolment.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is able to comprehend and willing to provide written informed consent to participate in this study.
- •Patients aged 30 years or older.
- •The patient has a clinical diagnosis of PD according to the diagnostic criteria of United Kingdom (UK) PD Society Brain Bank (2006) or Movement Disorder Society (MDS) Clinical Criteria (2015).
- •Disease severity stages I-III (Hoehn & Yahr Staging).
- •The patient is on treatment with levodopa/DOPA decarboxylase inhibitors (DDCI) for at least 1 year.
- •The patient has signs of wearing off phenomenon/end-of dose motor fluctuations for less than 2 years.
- •Patients starting treatment with opicapone as per local Summary of Product Characteristics (SmPC). Initiation of treatment with opicapone will be independent from participation in this observational study and must not be initiated for the purpose of study participation. The decision to treat patients with opicapone will occur before patients are enrolled in the study.
排除标准
- •The patient has any form of Parkinsonism other than PD.
- •The patient is participating in a clinical trial with an investigational drug or has concluded participation within 30 days.
- •The patient has any contraindication to opicapone according to SmPC.
- •The patient meets criteria for dementia in the Investigator's judgment.
- •The patient is currently treated with catechol-O-methyl transferase (COMT) inhibitors.
研究组 & 干预措施
Cohort 1
To evaluate the long-term effectiveness of opicapone in patients with Parkinson's disease (PD) and early motor fluctuations by means of the Patient Global Impression of Change (PGI-C) at 12 months after start of treatment
干预措施: Opicapone 50 mg (Drug)
结局指标
主要结局
Patient Global Impression of Change (PGI-C) score improvement (minimally, much or very much), no change or worsening (minimally, much or very much) 12 months after start of treatment.
时间窗: 12 months
To evaluate the long-term effectiveness of opicapone in patients with Parkinson's disease and early motor fluctuations by means of the PGI-C at 12 months after start of treatment.
次要结局
未报告次要终点