EUCTR2018-001312-30-GB进行中（未招募）1 期
SPRING - Seizure PRophylaxis IN Glioma - SPRING - Seizure PRophylaxis IN Glioma
Common Services Agency0 个研究点目标入组 804 人开始时间: 2018年10月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 804
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1)Patients with suspected cerebral glioma on MRI
- •?2)Capable of giving informed consent
- •?3)Patients must be = 16 years old
- •?4)Patients must have a Karnofsky performance status =70
- •?5)Patients must be able to safely swallow pills
- •6)Planned surgery for presumed glioma (biopsy or resection)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 8
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 474
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 322
排除标准
- •1)Pregnant
- •2)History of any type of seizure for at least 10 years prior to randomisation ?3)Known Severe Chronic Kidney Disease (CKD4 - eGFR < 30ml/min)
- •4)Concomitant methotrexate
- •5)Concomitant AED (including use for other reasons (e.g. pain))
- •6)Concomitant benzodiazepines
- •7)Hypersensitivity to levetiracetam
研究者
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