Epilepsie caused by auto antibodies modulated by Privigen - effects on brain excitability

Phase 1

• Conditions: Auto-immune epilepsy; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2019-002078-30-NL
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-24
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 55

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

- 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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br>- 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.