Clinical trial · Interventional
Immunoadsorption Therapy in Managing NMDAR Antibodies Encephalitis
Prospective Assessment of Efficacy of Immunoadsorption Therapy in Managing Childhood NMDA-Receptor (NMDAR) Antibodies Encephalitis
NCT03274375CI-TRIAL-00121136IANMDARcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anti-NMDAR Encephalitis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IA session | Drug | — | UNRESOLVED |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IA session
- description
- * 4 Rituximab injections * 10 IA sessions
- interventionNames
- Drug: IA session
- Drug: Rituximab
Primary outcomes (2)
- measure
- Change in Neurological status evaluated with the Pediatric Cerebral Performance Category Scale (PCPCS)
- timeFrame
- before and after the 10 IA sessions, 28 days maximum
- description
- at least reduction of 1 point in PCPCS between the two evaluations is expected
- measure
- Change in Neurological status evaluated with the modified Rankin Scale (mRS)
- timeFrame
- before and after the 10 IA sessions, 28 days maximum
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
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 ≥ 3 before first symptoms * 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
References
Publications (0)
Data not yet available
No reference posted for this study.