Early Treatment of Infants at High Risk of Developing West Syndrome With Low-dose Adrenocorticotropin Hormone (ACTH)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Evidence for improvement in the EEG one month following initiation of the 2 week course of low-dose ACTH.
研究概览
简要总结
West syndrome (WS) is a specific type of epilepsy (or seizure disorder) that has three features: infantile spasms (type of seizure), loss of milestones, and a specific pattern on electroencephalogram (EEG or brain wave test) called hypsarhythmia. The purpose of this study is to detect pre-hypsarhythmia in infants at high-risk for WS and determine whether treatment with ACTH will prevent WS.
详细描述
Hypothesis
Preemptive ACTH will halt the evolution of hypsarhythmia and improve the EEG patterns in infants with pre-hypsarhythmic EEG.
Aim. To determine whether a low dose ACTH improves EEG, we will repeat EEG one month after a 2 week course of daily ACTH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants with pre-hypsarhythmia (Type 3 EEG) between 2 months to 12 months of age.
排除标准
- •Infants with any of the following diagnoses:
- •A previous history of infantile spasms;
- •Known inborn error of metabolism;
- •Other symptomatic epileptic encephalopathy (e.g. Ohtahara syndrome).
研究组 & 干预措施
ACTH treatment
Infants with a Type 3 EEG (pre-hypsarhythmia) will be treated with ACTH for 2 weeks.
干预措施: adrenocorticotropin hormone (Drug)
结局指标
主要结局
Evidence for improvement in the EEG one month following initiation of the 2 week course of low-dose ACTH.
时间窗: 1 month
If pre-hypsarhythmia (Type 3) is detected, ACTH treatment is given for 2 weeks and an EEG is performed one month later. Primary outcome is improvement in EEG (as defined by assigned type).
次要结局
未报告次要终点