NL-OMON56107招募中2 期
Autoimmune epilepsy Modulated by IVIg - effects on Cortical Excitability, the AMICE study - AMICE study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 55
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Age of 18 years and older. - Epilepsy, with at least one seizure per week at
- •baseline. - Antibodies proven in serum and/or CSF in cell-based assay and/or
- •ELISA and on immunohistochemistry. In case of anti-GAD antibodies, antibody
- •titer with ELISA has to be >10,000 IU in serum or >100 IU in CSF.
排除标准
- •- Another identified cause of epilepsy (i.e. viral/bacterial encephalitis,
- •stroke, tumor). - Severe encephalitis in which escalation of therapy
- •(second-line immunotherapy, i.e. Rituximab or Cyclophosphamide) is expected
- •within the study period (mainly anti-NMDAR encephalitis with mRS 5, at the
- •ICU). - Use of immunotherapy < 3 months ago. - Use of monoclonal antibodies < 1
- •year ago. - Premorbid mRS >=3. - Known hypersensitivity to Privigen or
- •contraindication for Privigen, i.e. IgA deficiency. - Patient and/or legal
- •representative is withholding informed consent. - Patient objects after initial
- •informed consent.
研究者
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