Efficacy of add-on PEramPanel in focal motor Status epilepticus

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)0 个研究点目标入组 332 人开始时间: 2019年8月8日最近更新: 2020年7月27日

试验速览

暂无简介。

•1. Patients aged 18 years or above including the protected adults , with a focal motor status epilepticus, defined by prominent clinically objective focal motor symptoms (clonic, tonic, myoclonic, adversive or oculoclonic), lasting for more than 10 minutes before any treatment or repeated focal motor seizures during this period (= 4 seizures in 10 min).
•2. The focal motor status continues (or patients show = 2 focal motor seizures) 5 minutes after the beginning of administration of benzodiazepines,
•3. Affiliation to a French social security system (recipient or assign) excluding AME
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 332
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 332

•1. Known severe liver (Factor V <50 %) or kidney (glomerular filtration rate : 15-29 ml/min/1,72 m2) insufficiency,
•2. Women with known or clinically detected pregnancy,
•3. Patients with known allergies to perampanel or to any of the excipients mentioned in the SmPC
•4. Patients with postanoxic status
•5. Patients in coma (Glasgow<8).
•6. Patients with motor events for which a nonepileptic psychogenic origin is suspected
•7. Patients whose status epilepticus is linked to a pathological condition, such as trauma, who needed immediate surgery
•8. Known current treatment by perampanel
•9. Known galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption syndrome (rare hereditary diseases)
•10. Known participation in another trial with medication and/or previously included in PEPSI study

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