NCT00571155已完成4 期
Prospective Trial of Intravenous Levetiracetam in Patients With Primary Brain Tumors and at Least One Symptomatic Seizure Who Undergo Biopsy or Cytoreductive Surgery (HELLO-study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Feasibility of standardized treatment of patients with primary brain tumors and symptomatic epilepsy with levetiracetam in the period of neurosurgical intervention.
研究概览
简要总结
The purpose of this study is to determine the feasibility, efficacy and safety of intravenous and oral antiepileptic treatment with levetiracetam in patients with primary brain tumors and symptomatic epilepsy in the period of neurosurgical intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •age ≥ 18 years
- •suspected primary brain tumor by imaging
- •planned bioptical or cytoreductive surgery of the tumor
- •symptomatic epilepsy
- •Karnofsky performance score ≥ 70%
- •women with child bearing potential must perform sufficient contraception
- •sufficient haematologic, hepatic and renal function by laboratory testing
排除标准
- •treatment with other antiepileptic drugs other than levetiracetam in the last seven days before surgery
- •known allergic reaction to levetiracetam or other serious side effects
- •known, not tumor-induced, epilepsy
- •previous brain surgery
- •participation in another clinical trial
- •addiction to drugs or alcohol
- •pregnant or breast feeding women
研究组 & 干预措施
1
Other
干预措施: levetiracetam (Drug)
结局指标
主要结局
Feasibility of standardized treatment of patients with primary brain tumors and symptomatic epilepsy with levetiracetam in the period of neurosurgical intervention.
时间窗: 1 year
次要结局
- Efficacy, safety and tolerance of intravenous and oral levetiracetam in patients with primary brain tumors and symptomatic epilepsy in the period of neurosurgical intervention.(1 year)
研究者
研究点 (1)
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