Auto-immune epilepsy
Conditions
Interventions
Trade Name: Privigen
Product Name: Privigen
Pharmaceutical Form: Solution for infusion
Sponsors
Erasmus MC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Providing proof of a therapeutic effect of IVIg in autoimmune epilepsy, both clinically and serologically.;Secondary Objective: - Identifying an objective marker of therapy response in epilepsy, measuring cortical excitability by TMS-EEG, in vivo. - Providing evidence that patients’ antibodies affect cortical hyperexcitability, in vitro.;Primary end point(s): The proportion of patients with a seizure frequency reduction >50% and the proportion of patients that achieve full freedom of seizures in week 6, 7 and 8 (compared to the baseline frequency), for all patients with autoimmune epilepsy and compared by subgroup.;Timepoint(s) of evaluation of this end point: Seizure frequency is determined by the patient’s diary; by which the average seizure frequency at baseline (baseline frequency is determined by the seizure frequency in the 3 weeks prior to the start of the study) can be compared with week 6, 7, and 8. These averages of 3 weeks give a good impression of the epilepsy frequency. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Antibody levels pre- and post-treatment correlated to the seizure frequency, for all patients with autoimmune epilepsy and compared by subgroup. In addition, the amount of patients with antibody titer reduction >50% and the amount of patients that become antibody free, for all patients with autoimmune epilepsy and compared by subgroup. - Clinical improvement: - Changes in the PNS neurological scale and FAB at 3, 6, 12 and 18 weeks, for all patients with autoimmune epilepsy and compared by subgroup. - Changes in the MOCA at 6, 12 and 18 weeks, for all patients with autoimmune epilepsy and compared by subgroup. - Changes in the QOLIE-31-P at 3, 6, 12 and 18 weeks, for all patients with autoimmune epilepsy and compared by subgroup. - Proportion of patients with a relapse within 18 weeks, for all patients with autoimmune epilepsy and compared by subgroup at 18 weeks.;Timepoint(s) of evaluation of this end point: - Antibody levels: Blood samples will be achieved at baseline and after 5 days, 3 weeks, 3 weeks and 5 days, 6, 12, and 18 weeks. CSF will be achieved by lumbar puncture at baseline and after 6 weeks. - Seizure frequency: will be measured by the patient's diary. - Clinical improvement: the PNS neurological scale, FAB and QOLIE-31-P will be performed at baseline and 3, 6, 12 and 18 weeks. The MOCA will be performed at baseline and 6, 12 and 18 weeks. | — |
Countries
Netherlands
Contacts
Public ContactAutoimmune Encephalitis workgroup
Erasmus MC
Outcome results
None listed