Perampanel for the prevention of post-stroke epilepsy- efficacy and safety: a pilot phase II randomised controlled trial

Alfred Health0 个研究点目标入组 164 人开始时间: 2018年12月11日最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•1. Radiological (CT, CT perfusion or MRI) evidence of acute cortical ischaemic stroke or lobar haemorrhage within 7 days of symptom onset
•If enrolment is feasible prior to obtaining MRI (or MRI is contraindicated), cortical involvement can be inferred by either (1) evidence of large vessel (ICA, M1/M2) occlusion on CT angiography at admission or (2) clinical evidence of a cortical syndrome such as aphasia, neglect/inattention or visual field defect
•2. No previous anti-epileptic drug use
•3. Able to give informed consent or proxy consent
•4. Pre-admission mRS<4

•1. Preadmission Modified Rankin Scale (mRS) > 3
•2. Acute stroke more than 7 days from onset
•3. Previous ischaemic or haemorrhagic stroke within preceding 12 months
•4. Significant risk factors for non stroke-related epilepsy
•5. Previously diagnosed epilepsy (excluding benign childhood epilepsies)
•6. Additional epileptogenic intra-cranial pathology
•7. Previous intracranial surgery
•8. History of major psychiatric morbidity (such as psychiatric illness requiring hospitalisation or history of psychosis, major depression or suicidality) within the last 2 years
•9. Pregnant or breast-feeding
•10. Excessive alcohol or recreational drug use
•11. Unable to obtain informed consent from patient or substitute decision maker

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