Observational Retrospective Study of Effectivity and Tolerability in Patients With Lacosamide Medication
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 860
- 试验地点
- 1
- 主要终点
- The percentage of responders (patients with a crisis reduction of> 50%) at 12 months of treatment.
研究概览
简要总结
Lacosamide is an antiepileptic drug approved for using like adjuvant treatment in adults epileptic crisis.
Previous studies has granted to the adjuvant therapy a significant efficacy. This is an observational study, multicenter and retrospective, in patients with epilepsy. The aim of study is the evaluation of the adjuvant treatment with Lacosamide administered over 12 months.
The investigators will collect information from 860 patients in 13 spanish centers.
The secondary aim is assess the tolerability of treatment during 3,6 and 12 month.
详细描述
During the treatment we will performed a analysis in three different times (3, 6 and 12 month)for obtain a vision of tolerability and efficacy for Lacosamide in usual clinical practice. We intended describe the differences when we add Lacosamide to an antiepileptic drug, sodium channel blocker or no-sodium channel blocker in usual clinical practice.
Clinical data obtained through post-hoc analysis for registered pivotal studies made in highly refractory epileptic patients show that adjuvant treatment with Lacosamide has an extra efficacy compared with placebo. It is self-depended to the treatment with or without sodium channel blockers.
This study will allow us to obtain information about real existing most population where do not exist as high refractoriness as the pivotal studies.
The population of study is:
Patients with epilepsy, with plus that 18 years old patients, with initial partial crisis treated with Lacosamide according to usual clinical practice in Spain.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •The patient, male or female, over 18 years.
- •The patient has a diagnosis of prostate cancer of any kind, and has been treated with Lacosamide according to routine clinical practice.
- •The patient had at least one Partial Crisis during the year prior to initiation of treatment with Lacosamide.
- •The patient or their legal representative is reliable and able to adhere to the protocol (ie, is able to understand and complete the interview at the study visit), at the discretion of the investigator.
排除标准
- •Patient is participating in another study of a medicinal product research (PMI) or a medical implant.
- •Patients with other types of epilepsy.
- •Patients with a history of chronic alcoholism or drug abuse in the last year.
- •Patients who are not in possession of his faculties at the time of obtaining the Informed Consent.
研究组 & 干预措施
Lacosamide
patients with Partial Crisis of epilepsy treated with Lacosamide for at least 12 months
干预措施: lacosamide (Drug)
结局指标
主要结局
The percentage of responders (patients with a crisis reduction of> 50%) at 12 months of treatment.
时间窗: twelve months
The primary objective of the study is to assess the efficacy of through in patients with Partial Crisis, with a minimum duration of 12 months.
次要结局
- Percentage of patients reporting Adverse Events spontaneously potentially caused by the drug.(twelve months)