跳至主要内容
临床试验/NCT01620840
NCT01620840已完成不适用

Lacosamid-i.v.-Register

University Hospital Schleswig-Holstein1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2011年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
130
试验地点
1

研究概览

简要总结

Lacosamide is a new antiepileptic drug (AED) marketed as Vimpat with three different formulations, tablets, oral syrup and a solution for intravenous infusion. Lacosamide is approved as adjunctive therapy in epilepsy patients with partial onset seizures with or without secondary generalization. The i.v. solution is used in patients in which oral administration is not possible or adequate. Bioequivalence with oral tablets and safety could be demonstrated in healthy volunteers and in patients switched from tablets to Lacosamide i.v. solution. A recently published study demonstrates the feasibility of single loading doses up to 300 mg. The aim of this Lacosamide i.v. registry is to collect systematically data on the safety, tolerability and administration procedures when Lacosmide i.v. is used in routine daily clinical practice, mainly in hospitals. These data will help treating physicians to optimize the use of Lacosamide i.v. in clinical routine.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • •before any data are collected for any patient in this registry an ehtical committee must be notified of the registry and written data consent must be properly executed and documented

排除标准

  • 未提供

研究组 & 干预措施

Lacosamid-i.v. treatment

干预措施: Lacosamide 10mg/ml (Drug)

研究者

发起方
University Hospital Schleswig-Holstein
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ulrich Stephani

Prof. Dr. med. Ulrich Stephani

University Hospital Schleswig-Holstein

研究点 (1)

Loading locations...

相似试验

Lacosamid-i.v.-Register | 临床试验