ISRCTN70051203已完成3 期
Seizure PRophylaxis IN Glioma (SPRING): a Phase III randomised trial comparing prophylactic levetiracetam versus no prophylactic antiepileptic drug in patients with newly diagnosed presumed supratentorial glioma
Public Health Scotland0 个研究点目标入组 107 人开始时间: 2019年7月2日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 107
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients with suspected cerebral glioma on MRI or CT
- •2. Capable of giving informed consent
- •3. Patients must be =16 years old
- •4. Patients must have a Karnofsky performance status of >60
- •5. Patients must be able to safely swallow pills
- •6. Planned surgery for presumed glioma (biopsy or resection)
- •Capable of giving informed consent
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 - eGRR <30 ml/min)
- •4. Concomitant methotrexate
- •5. Concomitant Anti-Epileptic Drug (including use for other reasons (e.g. pain))
- •6. Concomitant Benzodiazepines
- •7. Hypersensitivity to Levetiracetam
研究者
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