IVIG Treatment for Refractory Immune-Related Adult Epilepsy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Immune Abnormalities
研究概览
简要总结
The purpose of the initial screening study is to find out if immune problems are an unrecognized cause of epilepsy in some patients. This study consists of a single blood sample, which will be tested for possible immune abnormalities. If enough patients are found who show immune abnormalities, those patients who are still having uncontrolled seizures will be invited to participate in a study of immune treatment with a compound called intravenous immunoglobulin (IVIG).
The study hypothesis is that a significant proportion of the young-onset, refractory, image-negative, partial-onset epilepsy population have an underlying autoimmune disorder, and many of these patients will respond to immune therapies, including IVIG.
At present, the importance of immune abnormalities in causing epilepsy, and the proper treatment when they are found, are both poorly understood. The investigators hope that this study will help us understand the cause of some cases that are difficult to treat.
详细描述
The study is divided into two phases:
Phase I: The investigators will screen for evidence of neuronal nuclear, cytoplasmic, and cell surface autoantibodies in our population of new onset refractory, imaging-negative young adult epilepsy patients. This part of the study involves obtaining a single blood sample, equal to about 2 teaspoons.
Phase 2: If a sufficient number of cases are identified, a double-blind crossover study of IVIG treatment will be performed in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of uncontrolled epilepsy with at least two seizures a month for three consecutive months.
- •Age 18 to
- •Clinical semiology or electroencephalogram (EEG) consistent with partial onset epilepsy.
- •Refractory to an adequate trial of two or more main-line anti-epileptic drugs.
- •Ability to keep a seizure diary.
- •Normal brain magnetic resonance imaging (MRI) - 3 Tesla, seizure protocol; with the exception of hippocampal sclerosis
排除标准
- •History of severe prematurity or neonatal distress, febrile seizures, moderate or sever traumatic brain injury, stroke, brain tumor, meningitis, encephalitis, neurocutaneous syndromes, or intracranial metal objects.
- •Evidence of psychogenic epilepsy.
- •History of convulsive status epilepticus.
- •History of primary generalized epilepsy in a first degree relative.
- •Known serious medical illness.
研究组 & 干预措施
all subjects
IVIG
干预措施: IVIG (Drug)
结局指标
主要结局
Immune Abnormalities
时间窗: Screening visit
neuronal nuclear, cytoplasmic, and cell surface autoantibodies
次要结局
未报告次要终点
研究者
Charles M. Epstein, MD
Professsor of Neurology - Divsion of Epilepsy
Emory University