Efficacy of add-on PEramPanel in Focal Motor Status Epilepticus
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 10
- 主要终点
- Administration or not of either (i) an additional second-line antiepileptic drug, either intravenous or orally, or (ii) a third-line (anesthetic drug)
研究概览
简要总结
Randomized controlled trial on focal motor status epilepticus (SE), studying the add-on efficacy of the enteral administration of perampanel (PER) to a conventional intravenous antiepileptic drug.
详细描述
In spite of the use of various antiepileptic drugs, the SE, generalized or focal, are refractory to the treatment in around 25 % of the cases. There is therefore a need to develop new therapy with novel synaptic targets.
New antiepileptic drugs emerge as potential drugs for SE. Perampanel (PER) is a new drug available for add-on therapy in patients with a focal epilepsy. The mechanism of action of this drug is original, as it is a non-competitive α-amino-3-hydroxy-5-methylisoxazole-4-propionate (AMPA) receptor antagonist. Several studies suggested that AMPA-mediated glutamatergic transmission plays an important rule during the SE.
In this study the investigator will focus on patients suffering from early focal motor SE, for several reasons:
(i) There is no randomized controlled double-blind trial in this population, and therefore no evidence to help physicians.
(ii) The investigator aims to perform a trial on early SE, after failure of only one drug (a benzodiazepine, recommended as first line treatment), in order to properly evaluate the effect of the tested drug (add-on of perampanel).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
- •The focal motor status continues (or patients show ≥ 2 focal motor seizures) 5 minutes or more after the beginning of administration of benzodiazepines. The delay between administration of benzodiazepines and randomization must not exceed 6 hours.
- •Affiliation to a French social security system (recipient or assign) excluding "Aide Médicale" Etat (AME)
排除标准
- •Known severe liver (Factor V <50 %) or kidney (glomerular filtration rate : 15-29 ml/min/1,72 m2) insufficiency
- •Women with known or clinically detected pregnancy
- •Patients with known allergies to perampanel or to any of the excipients mentioned in the summary of product characteristics(SmPC)
- •Patients with postanoxic status
- •Patients in coma (Glasgow<8)
- •Patients with motor events for which a nonepileptic psychogenic origin is suspected
- •Patients whose status epilepticus is linked to a pathological condition, such as trauma, who needed immediate surgery
- •Known current treatment by perampanel
- •Known galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption syndrome (rare hereditary diseases)
- •Known participation in another trial with medication and/or previously included in PEPSI study
研究组 & 干预措施
Perampanel
immediate enteral administration of Perampanel, 12 mg
干预措施: Perampanel (Drug)
Placebo
immediate enteral administration of placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Administration or not of either (i) an additional second-line antiepileptic drug, either intravenous or orally, or (ii) a third-line (anesthetic drug)
时间窗: Within de 6 hours after the perampanel or placebo administration
Administration or not of either (i) an additional second-line antiepileptic drug, either intravenous or orally, or (ii) a third-line (anesthetic drug), within the 6 hours following study drug (perampanel or placebo) administration
次要结局
- Time to seizure cessation(within the 6 hours after the administration of perampanel or placebo)
- Rate of patients with secondary generalized seizures(From hour 0 until hour 24 after the administration of perampanel or placebo)
- Subgroup analysis of the primary and secondary outcomes measure according to the etiology(At H0 (below or above the median of SE duration)
- Subgroup analysis of the primary and secondary outcomes measure according to duration of status epilepticus(At H0 (below or above the median of SE duration)
- Subgroup analysis of the primary and secondary outcomes measure according to type of conventional antiepileptic drug administrated(At H0 (below or above the median of SE duration))
- Seizure cessation(at 3 hours and 6 hours after the perampanel or placebo administration)
- The need for endotracheal intubation(within the 24 hours after the administration of perampanel or placebo)
- Progression to a convulsive generalized status epilepticus(From hour 0 until hour 24 after the administration of perampanel or placebo)
- Percentage of patients with altered consciousness(at 3 hours and 6 hours after the perampanel or placebo administration)
- Rate of patient with status epilepticus recurrence, in patients with seizure cessation(From hour 3 until hour 24 after the administration of perampanel or placebo)
- Mortality rate at the end of the study period(Up to 14 days (end of hospitalization) or 14 days if the patient is still hospitalized)
- Global neurological state at the end of the study period(Up to 14 days (end of hospitalization) or 14 days if patient is still hospitalized)
- Number of adverse events and their severity(from randomization until to 14 days after the administration of perampanel or placebo)
- Duration of hospitalization(From randomization untill 14 days after the administration of perampanel or placebo)
- Rate of patient with seizure recurrence(From hour 3 until hour 24 after the administration of perampanel or placebo)
- Glasgow Outcome Scale score at the end of the study period(Up to 14 days (end of hospitalization) or 14 days if the patient is still hospitalized)