RecruitingPhase 2NCT03274375

Immunoadsorption Therapy in Managing NMDAR Antibodies Encephalitis

Prospective Assessment of Efficacy of Immunoadsorption Therapy in Managing Childhood NMDA-Receptor (NMDAR) Antibodies Encephalitis


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

20 participants

Start Date

Jun 23, 2021

Study Type

INTERVENTIONAL

Conditions

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

Max Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment called immunoadsorption therapy — a process that filters harmful antibodies out of the blood — in children with a severe brain inflammation called anti-NMDAR encephalitis, where the body's immune system mistakenly attacks the brain. **You may be eligible if...** - You are between 0 and 18 years old - You have been diagnosed with definite anti-NMDAR encephalitis (confirmed by a specific antibody in the spinal fluid) - Your condition is still severe (scores of 4 or above on standard disability scales) even after receiving standard first-line treatments (steroids and/or intravenous immunoglobulin) **You may NOT be eligible if...** - You have brain inflammation caused by something other than NMDAR antibodies - Your condition has improved enough with first-line treatment - You cannot have a central line (IV catheter) placed safely - You are pregnant, breastfeeding, or a teenager without effective contraception - You have certain blood clotting problems, active serious infection, severe immune deficiency (such as AIDS), or an allergy to components used in the filtering process Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGIA session

10 IA sessions performed in 28 days maximum, using TherasorbTM adsorbers which contain sheep derived polyvalent antihuman-immunoglobulin coupled to SepharoseTM CL-4B.

DRUGRituximab

Concomitantly, Rituximab will be given each week for 4 weeks (one injection by week +/- 3 days): * at least 1 day before each IA session * the last injection will occur after the last session IA (minimum one day after)


Locations(1)

Hôpital Necker Enfants-Malades

Paris, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03274375


Related Trials