Using immunoadsorption therapy to treat pediatric anti-NMDAR encephalitis
Prospective Assessment of Efficacy of Immunoadsorption Therapy in Managing Childhood NMDA-Receptor (NMDAR) Antibodies Encephalitis
PHASE2 · Assistance Publique - Hôpitaux de Paris · NCT03274375
This study is testing if a new treatment combining immunoadsorption therapy with rituximab can help children with severe anti-NMDAR encephalitis feel better and recover faster.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Drugs / interventions | Rituximab, immunotherapy, cyclophosphamide |
| Locations | 1 site (Paris) |
| Trial ID | NCT03274375 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of immunoadsorption therapy (IA) in improving neurological outcomes for children suffering from severe anti-NMDAR encephalitis. The condition is characterized by various neurological symptoms, and current treatments often show limited success. The trial will involve administering IA sessions alongside rituximab to eligible pediatric patients who have already undergone first-line therapy. The goal is to assess whether this approach can lead to faster and more significant improvements in patients' conditions.
Who should consider this trial
Good fit: Ideal candidates are children aged 0-18 years with confirmed anti-NMDAR encephalitis who have not responded adequately to first-line treatments.
Not a fit: Patients with autoimmune encephalitis not associated with NMDAR antibodies or those who have severe contraindications for IA therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could lead to improved neurological recovery and reduced long-term complications for children with anti-NMDAR encephalitis.
How similar studies have performed: Previous studies have shown promising results with immunotherapy approaches in treating autoimmune encephalitis, suggesting potential for success with this novel application of IA.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris
- Hôpital Necker Enfants-Malades — Paris, France (RECRUITING)
Study contacts
- Study coordinator: Isabelle DESGUERRE, MD, PhD
- Email: isabelle.desguerre@aphp.fr
- Phone: +33 1.44.49.41.42
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anti-NMDAR Encephalitis, Anti-NMDAR encephalitis, IA adsorption, Paediatric