Immunoadsorption Therapy in Managing NMDAR Antibodies Encephalitis
The purpose of the study is to assess the efficacy of immunoadsorption therapy (IA) on improving the neurological status of severe pediatric anti-NMDAR encephalitis patients.
| Condition(s) | Anti-NMDAR Encephalitis |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | The purpose of the study is to assess the efficacy of immunoadsorption therapy (IA) on improving the neurological status of severe pediatric anti-NMDAR encephalitis patients. |
| Who can participate | Inclusion Criteria: * Age: 0-18 years inclusive * Autoimmune encephalitis with positive anti-NMDAR antibodies in CSF (definite anti-NMDAR encephalitis according to Graus's criteria (Graus et al., 2016). * PCPCS and mRS at 4 or over at the inclusion after first line therapy (steroids and/or IgIV) when Rituximab therapy is warranted * Parents or legal guardians signed the Informed consent form * Social insurance affiliation Exclusion Criteria: * Autoimmune encephalitis without NMDAR antibodies * PCPCS and mRS scores under 4 after first-line therapy * Contraindication to perform central vascular access * Pregnancy, breastfeeding or absence of effective contraception (including abstinence) in a pubertal patient. * Contraindication to perform IA therapy : * Clinical conditions that prohibit tra |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
| Locations | Paris, France |
| Start date | 2021-06-23 |
| NCT ID | NCT03274375 |
| Official listing | https://clinicaltrials.gov/study/NCT03274375 |