Status:
RECRUITING
Immunoadsorption Therapy in Managing NMDAR Antibodies Encephalitis
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Anti-NMDAR Encephalitis
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE2
Brief 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.
Detailed Description
Anti-NMDA-Receptor (NMDAR) encephalitis, the most frequent autoimmune encephalitis after Acute Demyelinating encephalomyelitis (ADEM), affects children with predominant movement disorders, decline of ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03274375
Start Date
June 23 2021
End Date
June 1 2026
Last Update
July 13 2023
Active Locations (1)
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1
Hôpital Necker Enfants-Malades
Paris, France, 75015