NCT00552526Unknown4 期
Comparing Ketogenic Diet With the Most Appropriate Antiepileptic Drug- a Randomized Study of Children With Mental Retardation and Drug Resistant Epilepsy
Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2007年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Comparing amount of patients with 100%, >90% and >50% reduction in number of seizures between the two groups of seizures
研究概览
简要总结
This is an open randomized controlled study in children with mental retardation and refractory epilepsy in which treatment with ketogenic diet (KD) is compared with treatment with the antiepileptic drug (AED), not tried by the patient before, which we consider to be the most appropriate AED for the patient.
详细描述
There are two trials in the study:
- To compare the effect of the ketogenic diet with the effect of the most appropriate AED after 4 months
- To evaluate the effect of the ketogenic diet after 4 and 13 months on the children who have been randomized to this treatment, the seizure frequency is compared with the frequency before start of treatment
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
- None
入排标准
- 年龄范围
- 2 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is mentally retarded
- •The patient has tried at least 3 different AED:s including one combination with two or more different AED:s.
- •The parents are willing to include their child in the study after written and verbal information.
- •Patients with all types of epilepsy can be included.
- •The patient has at least 6 seizures/month.
- •The patient is submitted to our epilepsy center.
- •The seizures are possible to count
- •The patient has either generalized epilepsy, multifocal epilepsy or an epilepsy where it is undetermined whether it is localized or generalized such as Dravet syndrome classified as G40.3-G40.9 in ICD X.
排除标准
- •The family is expected to have compliance problems with treatment and/or seizure registration.
- •The hospital which have submitted the patient is not willing to accept the inpatient stays and the procedures that are necessary for the project.
- •The patient's seizures are under acceptable control.
- •The patient has got a vagus nerve stimulator implanted within the last 18 months, has started a new antiepileptic drug within the last 2 months or has changed his antiepileptic drugs the last month.
- •The patient has a medical condition, for example a metabolic disease, where ketogenic diet is contraindicated.
- •The patient has a localized epilepsy classified as G40.0-G40.2 in ICD X.
- •The patient's nutritional status is not good enough or intake of fluid is to small to permit treatment with ketogenic diet.
- •The patient has within the last 2 months been using medications or herbal medications that has a considerable effect on glucose metabolism, such as oral glucocorticoids.
- •The patient has within the last 2 months been using medications or herbal medications that has a considerable effect on metabolism of AED:s.
- •The patient uses herbal medicine which can interact with AED or Ketogenic diet.
研究组 & 干预措施
Ketogenic diet
Active Comparator
干预措施: Ketogenic diet (Dietary Supplement)
AED
Active Comparator
Most appropriate antiepileptic drug
干预措施: Antiepileptic drug (AED) (Drug)
结局指标
主要结局
Comparing amount of patients with 100%, >90% and >50% reduction in number of seizures between the two groups of seizures
时间窗: 4 months
次要结局
- Comparing the parents´evaluation of change in quality of life and cognitive function between the two groups. The parents will answer a questionary.(Four months)
- Comparing side effects between the two groups(Four months)
- Comparing change in slow activity and epileptic activity by template matching on 24 hour EEG(Four months)
- Investigating side effects and change in number of seizures, change in EEG, quality of life and cognitive function after 13 months of treatment with the ketogenic diet(13 months)
- Is the effect of the ketogenic diet as good in children with severe mental retardation as in children with less severe learning disabilities?(4 and 12 months)
研究者
研究点 (1)
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