Immunoadsorption Therapy in Managing NMDAR Antibodies Encephalitis

NCT03274375 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-07-13

No results posted yet for this study

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.

Conditions

  • Anti-NMDAR Encephalitis

Interventions

DRUG

IA session

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

DRUG

Rituximab

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)

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Rémi SALOMON, Md, PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-23
Primary Completion
2024-07-31
Completion
2026-06-30

Countries

  • France

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03274375 on ClinicalTrials.gov