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Completed
NCT03274375
Immunoadsorption Therapy in Managing NMDAR Antibodies Encephalitis
Conditions: Anti-NMDAR Encephalitis
Sex: All
Ages: N/A – 18 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 20
Sponsor: Assistance Publique - Hôpitaux de Paris
Location: Hôpital Necker Enfants-Malades Paris Paris
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.
Eligibility Criteria
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 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
Source: ClinicalTrials.gov (NCT03274375). StuddyBuddy aggregates publicly available trial information.