Autoimmune epilepsy Modulated by IVIg – effects on Cortical Excitability, the AMICE study - AMICE study

Erasmus MC0 个研究点目标入组 55 人开始时间: 2020年3月24日最近更新: 2020年11月30日

适应症

试验速览

暂无简介。

•- 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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 35
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•- 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.

发起方