CompletedPhase 2

Immunoadsorption Therapy in Managing NMDAR Antibodies Encephalitis

France20 participantsStarted 2021-06-23

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Neurological status evaluated with the Pediatric Cerebral Performance Category Scale (PCPCS)

Timeframe: before and after the 10 IA sessions, 28 days maximum

Change in Neurological status evaluated with the modified Rankin Scale (mRS)

Timeframe: before and after the 10 IA sessions, 28 days maximum

Trial details

NCT IDNCT03274375

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-26

View on ClinicalTrials.gov More Anti-NMDAR Encephalitis trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Neurological status evaluated with the Pediatric Cerebral Performance Category Scale (PCPCS)

Timeframe: before and after the 10 IA sessions, 28 days maximum

Change in Neurological status evaluated with the modified Rankin Scale (mRS)

Timeframe: before and after the 10 IA sessions, 28 days maximum