Actively Recruiting

Phase 2
Age: 0 - 18Years
All Genders
NCT03274375

Immunoadsorption Therapy in Managing NMDAR Antibodies Encephalitis

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2023-07-13

20

Participants Needed

1

Research Sites

257 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Immunoadsorption Therapy in Managing NMDAR Antibodies Encephalitis

Who Can Participate

Age: 0 - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 0 to 18 years inclusive
  • Diagnosis of autoimmune encephalitis with positive anti-NMDAR antibodies in cerebrospinal fluid
  • PCPCS and mRS scores of 4 or higher after first-line therapy (steroids and/or intravenous immunoglobulins) when rituximab treatment is needed
  • Signed informed consent from parents or legal guardians
  • Affiliation with social insurance
Not Eligible

You will not qualify if you...

  • Autoimmune encephalitis without NMDAR antibodies
  • PCPCS and mRS scores under 4 after first-line therapy
  • Contraindications to central vascular access
  • Pregnancy, breastfeeding, or lack of effective contraception in pubertal patients
  • Contraindications to immunoadsorption therapy, including:
    • Clinical conditions prohibiting temporary volume changes
    • Conditions preventing anticoagulation with Heparin or ACD-A
    • History of hypercoagulability
    • Severe viral, bacterial, or fungal infections
    • Severe immune deficiencies such as AIDS
    • Suspected allergies to sheep antibodies or agarose

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hôpital Necker Enfants-Malades

Paris, France, 75015

Actively Recruiting

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Research Team

I

Isabelle DESGUERRE, MD, PhD

CONTACT

A

Aminata TRAORE

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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