Anti-NMDAR EncephalitisPhase 2IANMDARNCT03274375
Immunoadsorption Therapy in Managing NMDAR Antibodies Encephalitis
A Phase 2 study testing IA session and Rituximab in people with Anti-NMDAR Encephalitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Anti-NMDAR Encephalitis
- What is being tested?
- IA session and Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jun 2021to 12 Oct 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Assessment of Efficacy of Immunoadsorption Therapy in Managing Childhood NMDA-Receptor (NMDAR) Antibodies Encephalitis
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.
Read the detailed description
Anti-NMDA-Receptor (NMDAR) encephalitis, the most frequent autoimmune encephalitis after Acute Demyelinating encephalomyelitis (ADEM), affects children with predominant movement disorders, decline of consciousness, psychiatric symptoms, language dysfunction, seizures, dysautonomic symptoms. The cerebrospinal fluid (CSF) is most often abnormal with lymphocytic pleocytosis, CSF-specific oligoclonal bands with intrathecal synthesis of anti-NMDAR antibodies. Antibody titres in CSF and serum seem correlated with clinical outcome. Early start of immunotherapy has been reported to improve clinical outcome and associated with less relapses. In a recent large series (211 children/577), 77% of the patients were admitted to Intensive Care Unit (ICU) at the beginning. Within the group of children, first-line immunotherapy (95%) consisted of corticosteroids (89%), and/or intravenous immunoglobulins (IgIV) (83%), and/or plasma exchange (28%) with failure in 46%. The second-line immunotherapy consisting in rituximab (24%) and/or cyclophosphamide (16%) was proposed in 32%, and tended to be associated with good outcome (OR=3.35, CI: 0.86-12.98, p=0.081 for 53 children; statistical significance was achieved for the entire population including adults (OR: 2.69, CI: 1.24-5.80, p = 0.012) and less relapses.
In investigators' experience, the clinical benefit of rituximab is delayed over one month, while children go on worsening (50% admitted in ICU) thus claiming for faster removal of the antibodies. Plasma exchange is proposed in most of the series as alternative or combined treatment in the acute stage (first-line immunotherapy); recently, another plasmatherapy, immunoadsorption therapy (IA), has been reported as an efficient therapeutic approach in 11/13 patients. In this retrospective study, patients received a median of 6 IA sessions within a median period of 8 days with relevant clinical improvement. However these encouraging results and investigators' experience in few children need further prospective and standardized evaluation.
In IANMDAR study, each patient will receive 10 IA sessions during 28 days maximum. Rituximab will be given each week for 4 weeks (one injection by week +/- 3 days):
- at least 1 day before each IA session
- the 4 injections should be done before V2 (Day 28 after the inclusion)
To assess the efficacy of IA-therapy at short term, the neurological status of patients will be evaluated before and after the 10 IA sessions using the Pediatric Cerebral Performance Category Scale (PCPCS) and the modified Rankin Scale (mRS).
To assess the efficacy of IA-therapy at long term, patients will have a standardized follow-up during two years including neuropsychological evaluation at 1 year and at 2 years (see below for further details).
- Conditions
- Anti-NMDAR Encephalitis
- Being tested
- IA session, Rituximab
- Keywords
- Anti-NMDAR encephalitis, IA adsorption, Paediatric
- Medical subject headings
- Anti-N-Methyl-D-Aspartate Receptor Encephalitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IA sessionDrug
10 IA sessions performed in 28 days maximum, using TherasorbTM adsorbers which contain sheep derived polyvalent antihuman-immunoglobulin coupled to SepharoseTM CL-4B.
RituximabDrug
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 group | Role | What they receive |
|---|---|---|
| IA session | Experimental | * 4 Rituximab injections
* 10 IA sessions Receives: Drug: IA session; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Neurological status evaluated with the Pediatric Cerebral Performance Category Scale (PCPCS)
at least reduction of 1 point in PCPCS between the two evaluations is expected
Measured: before and after the 10 IA sessions, 28 days maximum
Change in Neurological status evaluated with the modified Rankin Scale (mRS)
at least reduction of 1 point in mRS between the two evaluations is expected
Measured: before and after the 10 IA sessions, 28 days maximum
Secondary outcomes (72)
Need of hospitalization in ICU and pediatric neurology unit
To assess immunoadsorption therapy at short term in pediatric severe anti-NMDAR encephalitis patients
Measured: 28 days
Duration of hospitalization in ICU and pediatric neurology unit
To assess immunoadsorption therapy at short term in pediatric severe anti-NMDAR encephalitis patients
Measured: 28 days
Need for mechanical ventilation
To assess immunoadsorption therapy at short term in pediatric severe anti-NMDAR encephalitis patients
Measured: 28 days
Need for vasopressive treatment
To assess immunoadsorption therapy at short term in pediatric severe anti-NMDAR encephalitis patients
Measured: 28 days
Time of recovery of independent daily-life activities
independent ambulation, enteral feeding, responsiveness to simple instructions and verbal communication (first word)
Measured: 28 days
Name and duration of medication for behavioral disorders and sleep disorders
To assess immunoadsorption therapy at short term in pediatric severe anti-NMDAR encephalitis patients
Measured: 28 days
Evolution of movement disorders assessed by the Movement Disorder Childhood Scale with video-taping, performed before and after IA therapy
To assess immunoadsorption therapy at short term in pediatric severe anti-NMDAR encephalitis patients
Measured: 28 days
Biological evolution of NMDAR antibodies tested in serum
before and after IA sessions
Measured: 28 days
Biological evolution of NMDAR antibodies tested in CSF
at diagnosis and after IA sessions
Measured: 28 days
Titration of NMDAR antibodies in serum before and after the first and the last (tenth) IA session
To assess immunoadsorption therapy at short term in pediatric severe anti-NMDAR encephalitis patients
Measured: 28 days
Duration of each immunoadsorption treatment
To assess tolerance of IA therapy
Measured: 28 days
Duration of use of medication for sedation by pharmaceutical class
to assess need of sedation
Measured: 28 days
Occurrence of hypotension with need for vasopressive treatment
To assess tolerance of IA therapy
Measured: 28 days
Occurrence of dysautonomic events (linked to the pathology): cardiac arrhythmia and heart rate events, flush, apnea
To assess tolerance of IA therapy
Measured: 28 days
Occurrence of vascular access complications : Infections (number, duration of antibiotics used), inadvertent removal, inefficiency (duration of retention of each vascular access)
To assess tolerance of IA therapy
Measured: 28 days
Total duration of the immunoadsorption therapy
To assess tolerance of IA therapy
Measured: 28 days
Total number of sessions
To assess tolerance of IA therapy
Measured: 28 days
Number of adsorbers used for each patient
To assess tolerance of IA therapy
Measured: 28 days
Adverse events of associated treatments
To assess tolerance of IA therapy
Measured: 28 days
PCPCS score
To assess Immunoadsorption therapy at long term
Measured: 3 months
mRS score
To assess Immunoadsorption therapy at long term
Measured: 3 months
PCPCS score
To assess Immunoadsorption therapy at long term
Measured: 6 months
mRS score
To assess Immunoadsorption therapy at long term
Measured: 6 months
PCPCS score
To assess Immunoadsorption therapy at long term
Measured: 1 year
PCPCS score
To assess Immunoadsorption therapy at long term
Measured: at 2 years
mRS score
To assess Immunoadsorption therapy at long term
Measured: 1 year
mRS score
To assess Immunoadsorption therapy at long term
Measured: at 2 years
Need of hospitalization in functional rehabilitation unit
To assess Immunoadsorption therapy at long term
Measured: 2 years
Duration of hospitalization in functional rehabilitation unit
To assess Immunoadsorption therapy at long term
Measured: 2 years
School attendance (special school or not) and rehabilitation attendance
To assess Immunoadsorption therapy at long term
Measured: 2 years
Neuropsychological assessment for cognitive and behavioral status with Wechsler scales
Measured: 1 year
Neuropsychological assessment for cognitive and behavioral status with Wechsler scales
Measured: at 2 years
Neuropsychological assessment for cognitive and behavioral status with Child Behavior Checklist (CBCL)
Measured: 1 year
Neuropsychological assessment for cognitive and behavioral status with Child Behavior Checklist (CBCL)
Measured: at 2 years
Neuropsychological assessment for cognitive and behavioral status with Brief Inventory of Executive Functions (BRIEF)
Measured: 1 year
Neuropsychological assessment for cognitive and behavioral status with Brief Inventory of Executive Functions (BRIEF)
Measured: at 2 years
Neuropsychological assessment for cognitive and behavioral status with Pediatric Quality of Life questionnaire (PedsQL)
Measured: 1 year
Neuropsychological assessment for cognitive and behavioral status with Pediatric Quality of Life questionnaire (PedsQL)
Measured: at 2 years
Visual attention evaluated with NEPSY scale
Measured: 1 year
Visual attention evaluated with NEPSY scale
Measured: at 2 years
Rey's figure test to evaluate visuospatial abilities and memory
Measured: 1 year
Rey's figure test to evaluate visuospatial abilities and memory
Measured: 2 years
CMS to assess memory
Measured: 1 year
CMS to assess memory
Measured: 2 years
Digit span to assess memory
Measured: 1 year
Digit span to assess memory
Measured: 2 years
Movement disorders assessment with the Movement Disorder Childhood Scale
To assess Immunoadsorption therapy at long term
Measured: 3 months
Movement disorders assessment with video-taping
To assess Immunoadsorption therapy at long term
Measured: 3 months
Movement disorders assessment with the Movement Disorder Childhood Scale
To assess Immunoadsorption therapy at long term
Measured: 6 months
Movement disorders assessment with video taping
To assess Immunoadsorption therapy at long term
Measured: 6 months
Movement disorders assessment with the Movement Disorder Childhood Scale
To assess Immunoadsorption therapy at long term
Measured: 1 year
Movement disorders assessment with the Movement Disorder Childhood Scale
To assess Immunoadsorption therapy at long term
Measured: 2 years
Movement disorders assessment with video-taping
To assess Immunoadsorption therapy at long term
Measured: 1 year
Movement disorders assessment with video-taping
To assess Immunoadsorption therapy at long term
Measured: at 2 years
Occurrence and date of relapses
Measured: 2 years
Presence of NMDAR antibodies in CSF
titration at 6 months
Measured: 6 months
Presence of NMDAR antibodies in CSF
titration at 1 year
Measured: 1 year
Presence of NMDAR antibodies in serum
titration at 3 months
Measured: 3 months
Presence of NMDAR antibodies in serum
titration at 6 months
Measured: 6 months
Presence of NMDAR antibodies in serum
titration at 1 year
Measured: 1 year
Proteinorachia
titration at 6 months
Measured: 6 months
Proteinorachia
titration at 1 year
Measured: 1 year
Presence of oligoclonal bands in serum
checked at 1 year
Measured: 1 year
Presence of oligoclonal bands in serum
checked at 3 months
Measured: 3 months
Presence of oligoclonal bands in serum
checked at 6 months
Measured: 6 months
Presence of oligoclonal bands in CSF
checked at 6 months
Measured: 6 months
Presence of oligoclonal bands in CSF
checked at 1 year
Measured: 1 year
Number of lymphocytes in serum
checked at 3 months
Measured: 3 months
Number of lymphocytes in serum
checked at 6 months
Measured: 6 months
Number of lymphocytes in serum
checked at 1 year
Measured: 1 year
Number of lymphocytes in CSF
checked at 6 months
Measured: 6 months
Number of lymphocytes in CSF
checked at 1 year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start23 Jun 2021
- Primary completion26 Oct 2023
- Study completion12 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anti-NMDAR EncephalitisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Rémi SALOMON, Md, PhD, Study chair, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03274375
- Sponsor's protocol ID
- P150919
- Other IDs
- 2016-A00259-42
- Acronym
- IANMDAR
- Status last verified
- Aug 2026
- First submitted
- 24 Jul 2017
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Assessment of Efficacy of Immunoadsorption Therapy in Managing Childhood NMDA-Receptor (NMDAR) Antibodies Encephalitis
- ClinicalTrials.gov ID
- NCT03274375
- Acronym / sponsor ID
- IANMDAR / P150919
- Conditions
- Anti-NMDAR Encephalitis
- Keywords
- Anti-NMDAR encephalitis, IA adsorption, Paediatric
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- 26 Oct 2023 (actual)
- Study completion
- 12 Oct 2025 (actual)
- First posted
- 6 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Anti-NMDA-Receptor (NMDAR) encephalitis, the most frequent autoimmune encephalitis after Acute Demyelinating encephalomyelitis (ADEM), affects children with predominant movement disorders, decline of consciousness, psychiatric symptoms, language dysfunction, seizures, dysautonomic symptoms. The cerebrospinal fluid (CSF) is most often abnormal with lymphocytic pleocytosis, CSF-specific oligoclonal bands with intrathecal synthesis of anti-NMDAR antibodies. Antibody titres in CSF and serum seem correlated with clinical outcome. Early start of immunotherapy has been reported to improve clinical outcome and associated with less relapses. In a recent large series (211 children/577), 77% of the patients were admitted to Intensive Care Unit (ICU) at the beginning. Within the group of children, first-line immunotherapy (95%) consisted of corticosteroids (89%), and/or intravenous immunoglobulins (IgIV) (83%), and/or plasma exchange (28%) with failure in 46%. The second-line immunotherapy consisting in rituximab (24%) and/or cyclophosphamide (16%) was proposed in 32%, and tended to be associated with good outcome (OR=3.35, CI: 0.86-12.98, p=0.081 for 53 children; statistical significance was achieved for the entire population including adults (OR: 2.69, CI: 1.24-5.80, p = 0.012) and less relapses.
In investigators' experience, the clinical benefit of rituximab is delayed over one month, while children go on worsening (50% admitted in ICU) thus claiming for faster removal of the antibodies. Plasma exchange is proposed in most of the series as alternative or combined treatment in the acute stage (first-line immunotherapy); recently, another plasmatherapy, immunoadsorption therapy (IA), has been reported as an efficient therapeutic approach in 11/13 patients. In this retrospective study, patients received a median of 6 IA sessions within a median period of 8 days with relevant clinical improvement. However these encouraging results and investigators' experience in few children need further prospective and standardized evaluation.
In IANMDAR study, each patient will receive 10 IA sessions during 28 days maximum. Rituximab will be given each week for 4 weeks (one injection by week +/- 3 days):
- at least 1 day before each IA session
- the 4 injections should be done before V2 (Day 28 after the inclusion)
To assess the efficacy of IA-therapy at short term, the neurological status of patients will be evaluated before and after the 10 IA sessions using the Pediatric Cerebral Performance Category Scale (PCPCS) and the modified Rankin Scale (mRS).
To assess the efficacy of IA-therapy at long term, patients will have a standardized follow-up during two years including neuropsychological evaluation at 1 year and at 2 years (see below for further details).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IA session | Experimental | Drug: IA session, Drug: Rituximab* 4 Rituximab injections * 10 IA sessions |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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 :
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IA session10 IA sessions performed in 28 days maximum, using TherasorbTM adsorbers which contain sheep derived polyvalent antihuman-immunoglobulin coupled to SepharoseTM CL-4B. | Drug | IA session |
| RituximabConcomitantly, 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) | Drug | IA session |
Primary outcome
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
at least reduction of 1 point in PCPCS between the two evaluations is expected
Change in Neurological status evaluated with the modified Rankin Scale (mRS)
Time frame: before and after the 10 IA sessions, 28 days maximum
at least reduction of 1 point in mRS between the two evaluations is expected
72 secondary outcomes
Need of hospitalization in ICU and pediatric neurology unit
Time frame: 28 days
Duration of hospitalization in ICU and pediatric neurology unit
Time frame: 28 days
Need for mechanical ventilation
Time frame: 28 days
Need for vasopressive treatment
Time frame: 28 days
Time of recovery of independent daily-life activities
Time frame: 28 days
Name and duration of medication for behavioral disorders and sleep disorders
Time frame: 28 days
Evolution of movement disorders assessed by the Movement Disorder Childhood Scale with video-taping, performed before and after IA therapy
Time frame: 28 days
Biological evolution of NMDAR antibodies tested in serum
Time frame: 28 days
Biological evolution of NMDAR antibodies tested in CSF
Time frame: 28 days
Titration of NMDAR antibodies in serum before and after the first and the last (tenth) IA session
Time frame: 28 days
Duration of each immunoadsorption treatment
Time frame: 28 days
Duration of use of medication for sedation by pharmaceutical class
Time frame: 28 days
Occurrence of hypotension with need for vasopressive treatment
Time frame: 28 days
Occurrence of dysautonomic events (linked to the pathology): cardiac arrhythmia and heart rate events, flush, apnea
Time frame: 28 days
Occurrence of vascular access complications : Infections (number, duration of antibiotics used), inadvertent removal, inefficiency (duration of retention of each vascular access)
Time frame: 28 days
Total duration of the immunoadsorption therapy
Time frame: 28 days
Total number of sessions
Time frame: 28 days
Number of adsorbers used for each patient
Time frame: 28 days
Adverse events of associated treatments
Time frame: 28 days
PCPCS score
Time frame: 3 months
mRS score
Time frame: 3 months
PCPCS score
Time frame: 6 months
mRS score
Time frame: 6 months
PCPCS score
Time frame: 1 year
PCPCS score
Time frame: at 2 years
mRS score
Time frame: 1 year
mRS score
Time frame: at 2 years
Need of hospitalization in functional rehabilitation unit
Time frame: 2 years
Duration of hospitalization in functional rehabilitation unit
Time frame: 2 years
School attendance (special school or not) and rehabilitation attendance
Time frame: 2 years
Neuropsychological assessment for cognitive and behavioral status with Wechsler scales
Time frame: 1 year
Neuropsychological assessment for cognitive and behavioral status with Wechsler scales
Time frame: at 2 years
Neuropsychological assessment for cognitive and behavioral status with Child Behavior Checklist (CBCL)
Time frame: 1 year
Neuropsychological assessment for cognitive and behavioral status with Child Behavior Checklist (CBCL)
Time frame: at 2 years
Neuropsychological assessment for cognitive and behavioral status with Brief Inventory of Executive Functions (BRIEF)
Time frame: 1 year
Neuropsychological assessment for cognitive and behavioral status with Brief Inventory of Executive Functions (BRIEF)
Time frame: at 2 years
Neuropsychological assessment for cognitive and behavioral status with Pediatric Quality of Life questionnaire (PedsQL)
Time frame: 1 year
Neuropsychological assessment for cognitive and behavioral status with Pediatric Quality of Life questionnaire (PedsQL)
Time frame: at 2 years
Visual attention evaluated with NEPSY scale
Time frame: 1 year
Visual attention evaluated with NEPSY scale
Time frame: at 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rémi SALOMON, Md, PhD study chair
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IA session and Rituximab in people with Anti-NMDAR Encephalitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.