DRKS00009032已完成不适用
on-interventional study X-TRASafety and efficacy of safinamide (Xadago®) as add-on therapy to levodopa in mid- to late-stage Parkinson’s disease patients – a non-interventional observational study in daily practice of German neurologists - X-TRA
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Zambon GmbH
- 入组人数
- 336
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •The patient is at least 18 years old at time point of enrollment into the study
- •Diagnosis of mid- to late-stage fluctuating PD
- •The patient has not yet been treated with Xadago®
- •The patient receives a stable dose of L-Dopa
- •The decision to initiate the treatment with Xadago® has been made by the treating physician considering the indications of the SmPC
- •The patient has been informed about the study in detail by the physician and the written informed consent of the patient (resp. his/her statutory representative) to the participation in the study has been obtained
排除标准
- •Hypersensitivity to the active substance or to any of the excipients
- •Concomitant treatment with other monoamine oxidase (MAO) inhibitors
- •Concomitant treatment with pethidine
- •severe hepatic impairment
- •albinism, retinal degeneration, uveitis, inherited retinopathy or severe progressive diabetic retinopathy
- •Also, following patients will not be included in the study according to the SmPC:
- •Women of childbearing potential without adequate contraception
- •Pregnant women
- •Breast-feeding women
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