Levetiracetam and Pregabalin for Monotherapy in Patients With Brain Tumors and Seizures. A Phase II Randomized Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Survival without occurrence of status epilepticus, 2 seizures with consciousness impairment, need to add a second antiepileptic drug (AED) (except transitory benzodiazepine), and need to discontinue study drug for lack of efficacy or adverse events
研究概览
简要总结
RATIONALE: Levetiracetam and pregabalin are drugs that treat seizures. It is not yet known which drug is more effective in treating seizures caused by primary brain tumors.
PURPOSE: This randomized phase II trial is studying the side effects and how well levetiracetam or pregabalin work in treating seizures in patients undergoing chemotherapy and/or radiation therapy for primary brain tumors.
详细描述
OBJECTIVES:
- To determine the safety and efficacy of antiepileptic drug monotherapy comprising levetiracetam or pregabalin in treating seizures in patients undergoing chemotherapy and/or radiotherapy for primary brain tumors.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive levetiracetam.
- Arm II: Patients receive pregabalin. Patients are followed at 2 weeks, 2 months, 6 months, and then at 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Levetiracetam
Patients assigned to Levetiracetam are treated with the initial dose of 2 x 250mg per day up to one year
干预措施: pregabalin (Drug)
Pregabalin
Patients assigned to Pregabalin are treated with the initial dose of 2 x 75mg per day up to one year
干预措施: levetiracetam (Drug)
结局指标
主要结局
Survival without occurrence of status epilepticus, 2 seizures with consciousness impairment, need to add a second antiepileptic drug (AED) (except transitory benzodiazepine), and need to discontinue study drug for lack of efficacy or adverse events
时间窗: baseline to visit at 12 months
次要结局
- Need to add a second AED(baseline to visit at 12 months)
- Adverse events(baseline to visit at 12 months)
- Anxiety(baseline to visit at 12 months)
- Study drug discontinuation(baseline to visit at 12 months)
- Occurrence of consciousness-impairing seizures or status epilepticus(baseline to visit at 12 months)
- Mortality(baseline to visit at 12 months)
研究者
Dr Andrea Rossetti
Médecin associé
Centre Hospitalier Universitaire Vaudois