Comparative Study of Dietary and Immunological Management of Refractory Epilepsy in Children Attending Assiut Pediatric University Hospital
试验速览
- 阶段
- 4 期
- 入组人数
- 140
- 主要终点
- a-seizure frequency b-antiepileptic drugs c-compliance to treatment d-number of hospital admission
研究概览
简要总结
- Comparison of the efficacy of Rituximab and ketogenic diet in controlling refractory seizures versus the traditional lines as corticosteroid and trace elements.
- Improving the management of children with refractory seizures
详细描述
- Definition of refractory epilepsy
A task force of the International League Against Epilepsy proposed that drug-resistant epilepsy be defined as failure of adequate trials of two tolerated and appropriately chosen and used antiseizure drug schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom (1)
. This requires application of the intervention at adequate strength/dosage for a sufficient length of time (2)..Terms refractory" intractable", drug-resistant" pharmaco-resistant" have been used interchangeably in several documented literature in different time periods (3). The first antiseizure drug fails in 20 to 40 percent of children with epilepsy; lack of efficacy and side effects contribute to treatment failure (4)
Epidemiology About 10-20 % children with epilepsy develop drug refractory epilepsy (5).In a systematic review of 35 observational studies that included over 13,000 patients with epilepsy and 3900 patients with drug resistant epilepsy( DRE), the pooled prevalence of (DRE) was 30 percent, and the pooled incidence proportion was 15 percent (6).
Risk factors
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
- 1 Month 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1-Age 1 month up to 17 years 2-Both male and female 3-Epileptic patient on two tolerated and appropriately chosen and used antiepilptic drugs with no response
排除标准
- •1-Neonate 2-Epieptic patient on monotherapy 3-Conditions mimic epilepsy 4-Pseudo refractioness 5-Absolute contraindications for the use of diet therapy include carnitine deficiency (primary), carnitine palmitoyltransferase (CPT) I OR II deficiency, carnitine translocase deficiency, β-oxidation defects, pyruvate carboxylase deficiency, and porphyria 6-Contraindication for Rituximab:
- •Hypersensitivity to any component, murine proteins. b. Heart failure c. Active infection
研究组 & 干预措施
RITUXIMAB
rituximab INTRAVENOUS 750MG/m2 every 2 weeks for 2 doses
干预措施: RiTUXimab Injection [Rituxan] (Drug)
KETOGENIC DIET
The common element of these different approaches is variable reduction in the amount of carbohydrate with appropriate increase in fat.
Diets that produce a state of ketosis are referred to as ''ketogenic"
干预措施: RiTUXimab Injection [Rituxan] (Drug)
TRACE ELEMENTS
. Essential trace elements that include zinc, copper, magnesium, and selenium
干预措施: RiTUXimab Injection [Rituxan] (Drug)
CORTICOSTEROID
corticosteroid pulse therapy 30 mg /kg /day for 5 days monthly for 6 month
干预措施: RiTUXimab Injection [Rituxan] (Drug)
结局指标
主要结局
a-seizure frequency b-antiepileptic drugs c-compliance to treatment d-number of hospital admission
时间窗: 1 YEAR
number of attacks of fits during monitoring
次要结局
未报告次要终点
研究者
Nancy Alaa
Principle investigator
Assiut University