An Observational, Prospective, Multinational, Multicentre Study Comparing the Effectiveness of Safinamide, Rasagiline and Other "Standard Of Care" as Add-On Therapy to Levodopa (L-Dopa) in Parkinson's Disease (Pd) Fluctuating Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Zambon SpA
- 入组人数
- 1,235
- 试验地点
- 3
- 主要终点
- The change from baseline to the end of study of the PDQ-39 total score.
研究概览
简要总结
The purpose of this study is to evaluate how safinamide, rasagiline and other SoC drugs are associated with the quality of life of PD patients by means of the Parkinson's Disease Questionnaire (PDQ)-39 items.
详细描述
Safinamide is an alpha-aminoamide derivative, structurally unrelated to any other drug for the treatment of PD, with a dual mechanism of action (dopaminergic and non-dopaminergic). In particular, it is a potent, selective and reversible MAO-B inhibitor, and it is a glutamate modulator through the sodium channels blockade.
Safinamide has been approved in Europe for the treatment of mid- to late-stage patients with idiopathic PD and fluctuations as add-on therapy to a stable dose of levodopa (alone or in combination with other PD medications).
Rasagiline is an irreversible MAO-B inhibitor, with unknown activity on other neurotransmitters. Rasagiline has been approved in Europe for the treatment of idiopathic PD as monotherapy or as add-on to levodopa in patients with end of dose fluctuations.
The aim of this observational study is to evaluate the effectiveness of safinamide, rasagiline and other "standard of care" (SoC) drugs when prescribed in clinical routine as add-on to L-dopa in terms of quality of life, improvement of chronic pain, change in Anti-Parkinson treatment (modification of doses, addition or withdrawal or other Anti-Parkinson drugs, etc.), use of concomitant pain-killer medications, compliance to the PD treatment, hospitalizations and use of other healthcare resources, and number of lost working days.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both genders ≥ 18 years of age, with a clinical diagnosis of idiopathic PD according to UK Brain Bank diagnostic criteria (12) for whom safinamide, rasagiline or any other anti-Parkinson drugs are prescribed according to the current Summary of Product Characteristics (SmPC).
- •Willing to participate in the study and able to understand and sign the written informed consent form.
- •Patients on a stable anti-Parkinson therapy, always including L-dopa + dopa-decarboxylase inhibitor (DDI), with or without other anti-Parkinson medications.
- •Patients must be treated with safinamide, rasagiline or other SoC drugs as add-on to L-dopa for no more than 2 months prior to the baseline visit, according to the clinical practice.
排除标准
- •Patients with any form of Parkinsonism other than idiopathic PD.
- •Patients for whom safinamide, rasagiline or any other anti-Parkinson drug are contraindicated according to the current SmPC.
- •Patients known to be pregnant.
- •Patients treated with safinamide or rasagiline who receive other concomitant MAO-B inhibitors.
- •Patients treated with other SoC drugs who receive safinamide or rasagiline.
- •Previous participation in a clinical trial with an investigational drug or medical device in the 3 months prior to the baseline visit.
结局指标
主要结局
The change from baseline to the end of study of the PDQ-39 total score.
时间窗: The validated PDQ-39 assesses health-related quality improvement (Qi); an improvement in Qi corresponds to a decrease of the PDQ-39 total score.
Over a period of 12 months
次要结局
- PDQ-39 total score(6 months)
- anti-Parkinson drugs number(6 and 12 months)
- new pain-killer medications and daily dosage of pain-killer medications(6 and 12 months)
- PDQ-39 sub-scores (domains and single items)(6 and 12 months)
- UPDRS III score(6 and 12 months)
- number of pain-killer medications(6 and 12 months)
- Healthcare resources(6 and 12 months)
- NRS.(6 and 12 months)
- The use of concomitant pain-killer medications(6 and 12 months)
- Safety Endpoints(6 and 12 months)
- new anti-Parkinson drugs(6 and 12 months)
- number of working-days lost(6 and 12 months)