Rapid Oral Treatment of Cluster Epileptic Seizures. Efficacy Assessment of Levetiracetam in Cluster Seizures.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 112
- 试验地点
- 13
- 主要终点
- Ratio of patients who are free of seizure between H3 and H24 in both groups.
研究概览
简要总结
This is a double blind, placebo controlled, add-on clinical trial, of levetiracetam efficacy and safety, in epilepsy cluster seizure.
Efficacy is evaluated in the range of 2 to 24 hours after taking the tablet. If the patient has a seizure during this interval, he is considered as a non-respondent patient.
详细描述
Seizure clustering has been defined as a series of unusual frequency of seizures with return to baseline between events. The most common definition of cluster seizure is three seizures per 24 hours.
The usual treatment of cluster seizure is benzodiazepin. This is recognized efficient therapy but has many side effects. Thus it is important to develop as an new therapeutic to improve patient care. Levetiracetam is an antiepileptic drug used in addition to other antiepileptic drugs with less side effects than benzodiazepin.
The aim of this study is to evaluate the effectiveness and safety of levetiracetam in epilepsy cluster seizure.
This is a double blind, placebo controlled, add-on clinical trial with two phases :
Phase 1 : Double blind phase during 24 hours (H0 to H24). After consent signature and randomization, the patient takes two tablets of levetiracetam or placebo. If the patient has a seizure between H3 and H24, he is considered as a non-respondent patient. If there is a risk of rapid evolution to an statue epilepticus, the investigator can break the blind and adapt the patient treatment accordingly.
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
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 65
- •Drug resistant epilepsy, partial seizure
- •Epilepsy diagnosed for more than 2 years
- •Epilepsy treated for more than 1 year with no change of treatment in the month before the enrolment
- •Onset of cluster seizure in the 24 hours before enrolment
- •For women : effective contraception
- •Affiliation to the French social security
排除标准
- •Inability to tolerate levetiracetam, likely poor compliance
- •Patient taking antiepileptic treatment (benzodiazepine) in addition to current treatment during the last 48h
- •Patient taking 1g/day of levetiracetam with Creatinin clearance < 50ml/min
- •Patient taking 2g/day of levetiracetam with Creatinin clearance < 80ml/min
- •Patient taking more than 2g/day of levetiracetam
- •Hepatic or cardiovascular pathology
- •Progressive psychiatric pathology
- •Degenerative neurologic disease
- •Cluster seizure due to an acute symptomatic reason
- •Disorder of consciousness
- •Suspicion of status epilepticus or rapid evolution to status epilepticus
- •Suspicion of psychogenic nonepileptic seizure
- •Pregnant woman or nursing woman
- •Suicidal thoughts
- •Incapacity to give consent, minor patient
结局指标
主要结局
Ratio of patients who are free of seizure between H3 and H24 in both groups.
次要结局
- Items 1,2,3 of the Clinical Global Impression scale.
- Side effects during the study.
- Time between H0 and the last seizure.
- Type and ratio of epileptic fit between H0 and H24.
- Number of seizures occured between H3 and H10, H10 and H17, H17 and H24, corresponding to the half-time of the treatment (7 hours).
- Description of therapeutic adaptation at 1 month after patient enrolment.