ACTRN12617000073303终止2 期
Perampanel for the prevention of glioma associated seizures – efficacy and safety: a pilot phase II randomised controlled trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •Pre-operative phase (ie inclusion for 7T MRI)
- •1. 18 – 80 years
- •2. Radiological diagnosis of a supratentorial WHO grade II-III glioma
- •3. Planned surgical resection or biopsy of lesion
- •4. 3T MRI performed as clinical standard of care
- •5. Able to give informed consent
- •6. No pre-operative seizure
- •Post-operative phase (ie inclusion for treatment intervention)
- •1. 18-80 years
- •2. Diagnosis of WHO grade II-III glioma
- •3. Less than 3 weeks from date of glioma resection or biopsy
- •4. No seizures prior to randomisation
排除标准
- •1. Previous non-tumour related neurosurgical procedures (excluding biopsy of glioma)
- •2. Pre-operative chemotherapy or radiotherapy
- •3. Receiving >1000mg daily of levetiracetam or multiple concurrent anti-epileptic drugs at time of randomization
- •4. Contraindication to 7T MRI
- •5. Significant risk factors for non-tumour associated epilepsy
- •- Previously diagnosed epilepsy (excluding benign childhood epilepsies)
- •- Additional epileptogenic intra-cranial pathology (including intra-cranial complications from glioma resection)
- •6. History of major psychiatric morbidity (such as psychiatric illness requiring hospitalisation or history of psychosis, major depression or suicidality) within the last 2 years
- •7. Pregnant or breast-feeding
- •8. Excessive alcohol or recreational drug use
研究者
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