Clinical Study Evaluating the Safety and Efficacy of N-acetyl Cysteine in Children With Drug-Resistant Epilepsy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- effectivness of acetyl cysteine for controlling epileptic seizures in children with drug resistant epilepsy.
研究概览
简要总结
This study aims at investigating the possible efficacy and safety of N-acetyl cysteine as adjuvant therapy in the treatment of drug-resistant epilepsy
详细描述
N-acetyl-cysteine (NAC), a glutathione precursor, is proven to activate the nuclear factor E2-related factor 2( Nrf2) in mouse models of status epilepticus, thus inhibiting high mobility group box 1 (HMGB1) cytoplasmic translocation in the hippocampal neural and glial cells and preventing the linkage between oxidative stress and neuroinflammation for which the redox-sensitive protein HMGB1 is central. Therefore,It may be useful as an adjuvant in treating various medical conditions, especially neuropsychiatry.
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)
盲法说明
double blind
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 3-18 years with intractable childhood-onset epilepsy.
- •All patients are diagnosed to have drug-resistant epilepsy (refractory epilepsy) according to the ILAE definition.
- •The subject is willing and able to comply with the study requirements
排除标准
- •Any metabolic conditions that might increase the risks associated with trial participation or investigational product administration, such as hepatic enzyme elevation greater than twice normal and/or a GFR < 60 mL/min/1.73 m2 or electrolyte imbalance.
- •Patients with Known allergy to N-acetyl cysteine.
- •Patients taking antioxidant and/or anti-inflammatory medications
研究组 & 干预措施
Control group
30 patients will receive standard antiepileptic drug plus placebo capsules for 6 months.
干预措施: Placebo (Drug)
N-acetyl cysteine group
30patients will receive 10 mg/kg of N-acetyl cysteine capsules together with their standard antiepileptic drug for 6 months.
干预措施: N-acetyl cysteine (Drug)
N-actyl cysteine group
30 patients will receive 40 mg/kg of N-acetyl cysteine capsules together with their standard antiepileptic drug for 6 months.
干预措施: NAc (Drug)
结局指标
主要结局
effectivness of acetyl cysteine for controlling epileptic seizures in children with drug resistant epilepsy.
时间窗: 6 months
effectivness can be defined as more than 50% reduction in number of seizures.
次要结局
- analyze the differences of improvement of quality of life via using Helth related quality of life questionnaire(6 months)
研究者
Amira Roshdy
Assistant Lecturer of Clinical Pharmacy
Tanta University