Immunoadsorption Therapy in Managing NMDAR Antibodies Encephalitis
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Study ID
- NCT03274375
- Phase
- PHASE2
- Status
- Completed
Conditions
- Anti-NMDAR Encephalitis
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - 18 Years
- Healthy Volunteers
- Not accepted
Interventions
- IA session — DRUG10 IA sessions performed in 28 days maximum, using TherasorbTM adsorbers which contain sheep derived polyvalent antihuman-immunoglobulin coupled to SepharoseTM CL-4B.
- Rituximab — DRUGConcomitantly, 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
- First listed
- Sep 6, 2017
- Start date
- Jun 23, 2021
- Status verified
- Aug 2026
- Primary completion
- Oct 26, 2023
- Completion
- Oct 12, 2025
Study Design
- Enrollment
- 20 participants (actual)
- 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 ]