Immunoadsorption Therapy in Managing NMDAR Antibodies Encephalitis

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT03274375
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Anti-NMDAR Encephalitis

Eligibility Criteria

Sex
ALL
Age
N/A - 18 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 23, 2021
Status verified
Jul 2023
Primary completion
Jul 31, 2024
Completion
Jun 30, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: IA session
    * 4 Rituximab injections * 10 IA sessions

Primary Outcome Measure

Change in Neurological status evaluated with the Pediatric Cerebral Performance Category Scale (PCPCS) [ Time Frame: before and after the 10 IA sessions, 28 days maximum ]

Central Contacts