Immunoadsorption Therapy in Managing NMDAR Antibodies Encephalitis

• Status: Not yet recruiting
• Trial end date: 2025-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Antibodies; Rituximab

Criteria

Inclusion Criteria:

• Age: 0-16 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 transitory volume changes

• Indications that prohibit anticoagulation using Heparin and/or ACD-A solutions

• History of hypercoagulability

• Generalized viral, bacterial and/or mycotic infections

• Severe immune deficiencies (e.g. AIDS)

• Suspected allergies against sheep antibodies or agarose