Autoimmune epilepsy Modulated by IVIg - effects on Cortical Excitability, the AMICE study
- Conditions
- 1000381610039911Autoimmune epilepsy / epilepsy caused by brain inflammation by auto-antibodies
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 55
- 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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The proportion of patients with a seizure frequency reduction >50% and the<br /><br>proportion of patients that achieve full freedom of seizures in week 6, 7 and 8<br /><br>(compared to the baseline frequency), for all patients with autoimmune epilepsy<br /><br>and compared by subgroup.</p><br>
- Secondary Outcome Measures
Name Time Method