Double Blind, Randomised, Cross-over Study Melatonin Versus Placebo in the Lennox-Gastaut Syndrome: Neurophysiological and Neuropsychological Effects
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- diminution of at least 50% of the nocturnal interictal discharges and tonic seizures with the melatonin treatment
研究概览
简要总结
Lennox-Gastaut syndrome is a severe epileptic encephalopathy of childhood. In that syndrome, various type of seizure occur, mainly tonic seizures, atonic seizures and atypical absences. The tonic seizure occur mostly at night.
The hypothesis is that the melatonin could have a positive effect in that syndrome, by reducing the epileptic activity (assessed in the polysomnographic record by counting the number of interictal and ictal discharges) and stabilizing the structure of sleep.
The study is double blind, randomised, cross-over designed.
详细描述
The aim of the trial is to study the efficacity of melatonin in the Lennox-Gastaut syndrome, by assessing the reduction of the seizure/interictal discharges in polysomnography and assessing the sleep structure.
After initial recruitment, the baseline visit includes a polysomnography. The patients will then be randomised in two groups: melatonin (1 cp containing melatonin 2 mg 1x/d 1h before sleep) vs placebo (1 cp 1x/d 1h before sleep). The treatment (melatonin or placebo) will be given for 1 month.
After 1 month, the treatment will be stopped and another polysomnography will be recorded.
The patients will take no treatment (wash-out period) for 15 days. The second treatment phase is cross-over: the group that had melatonin in the first phase will take placebo for one month, and the group that had placebo in the first treatment phase will take melatonin for one month. A last polysomnography will be recorded after the second treatment phase.
The other medications (antiepileptic drugs) taken by the patients before the trial will not be modified.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lennox-Gastaut syndrome (based on ILAE classification, 1989)
- •light mental retardation (QI 50-69)
- •french mother tongue
- •having someone helping the patient (parent and/or referent educator)
- •informed consent have been given by the patient / guardian
- •absence of concomitant evolutive affection or associated sleep pathologies
- •collaboration of the patient, ability to complete all aspects of the trial.
排除标准
- •epileptic syndrome other than Lennox-Gastaut, other neurologic and/or psychiatric disease
- •moderate to severe mental retardation (QI < 50)
- •psychiatric disease that could interfere with the diagnostic procedure
- •specific sleep disorder (anamnestic and diagnosed on the polygraphic record), for example: sleep apnea syndrome, narcolepsy, restless legs syndrome, periodic legs movements, etc...
研究组 & 干预措施
placebo
干预措施: placebo (Drug)
melatonin
干预措施: melatonin (Drug)
结局指标
主要结局
diminution of at least 50% of the nocturnal interictal discharges and tonic seizures with the melatonin treatment
时间窗: assessed after 1 month and 2.5 months
The patients will have three polysomnographic recording: at the baseline, one month after initiating the treatment (melatonin or placebo) and one month after the cross-over phase. The number of tonic seizure and if interictal discharges will be assessed. The primary outcome measure is a diminution of \> 50% of the seizures/interictal discharges with the melatonin treatment.
次要结局
- augmentation of at least 15% of the amount of deep slow sleep with the melatonin treatment(assessed after 1 month and 2.5 months.)