NMDAR Autoimmune EncephalitisMETANCT07133113
Medium-term Effects of Treatments in Autoimmune Encephalitis
An observational study of NMDAR Autoimmune Encephalitis and LGI1 Antibody Associated Encephalitis, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Autoimmune encephalitides are severe neurological disorders requiring urgent treatment, even though there is no standard guideline by lack of empirical evidence. Commonly used treatments are divided into so-called first-line (steroids, intravenous immunoglobulins, plasma exchanges) and second-line (rituximab… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- NMDAR Autoimmune Encephalitis, LGI1 Antibody Associated Encephalitis, CASPR2-Antibody
- What is being tested?
- We aim to assess the clinical response to the treatment initiation protocols most commonly used in autoimmune encephalitis (first-line, first-line with rituximab, dual immunosuppression).
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2024to 1 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All Patients with autoimmune encephalitis defined anti-GAD NMDAR, LGI1, CASPR2, IgLON5 or GFAP and untreated within the previous 30 days
Who may be able to join
- Adult or child patient with encephalitis defined as anti-GAD, NMDAR, LGI1, CASPR2, IgLON5 or GFAP
- Untreated or with a decision to treat within the previous 30 days.
Who cannot join
- Refusal by the referring doctor to participate or refusal by the patient mentioned in the objection to the use of his/her clinical data.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hospices Civil de Lyon
Bron, 69677
Bastien JOUBERT, Professor, 04 78 86 17 89, bastien.joubert@chu-lyon.fr
About this study
Official title: Medium-term Effects of Treatments in Autoimmune Encephalitis (META): a Real-life, Observational Prospective Study
Autoimmune encephalitides are severe neurological disorders requiring urgent treatment, even though there is no standard guideline by lack of empirical evidence. Commonly used treatments are divided into so-called first-line (steroids, intravenous immunoglobulins, plasma exchanges) and second-line (rituximab, cyclophosphamide, tocilizumab, others), and may be used in association or sequentially. There is no standard practice, and initial treatment protocol may consist in first-line alone, first-line with rituximab, or first-line with dual immunosuppression (rituximab and cyclophosphamide). Absence of clear response to initial treatment in the first 4 to 6 weeks may indicate undertreatment and is generally followed by treatment escalation, mostly to dual immunosuppression. However, as the frequency of non-responders to initial treatment is unknown, it is still unclear whether dual immunosuppression should be offered to all patients from inception.
- Conditions
- NMDAR Autoimmune Encephalitis, LGI1 Antibody Associated Encephalitis, CASPR2-Antibody, IgLON5, GAD65, GFAP
- Being tested
- We aim to assess the clinical response to the treatment initiation protocols most commonly used in autoimmune encephalitis (first-line, first-line with rituximab, dual immunosuppression).
- Keywords
- Paraneoplastic neurological disorder, autoimmune encephalitis
- Medical subject headings
- Autoimmune Diseases of the Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
We aim to assess the clinical response to the treatment initiation protocols most commonly used in autoimmune encephalitis (first-line, first-line with rituximab, dual immunosuppression).Other
The patients will be identified via the French Nationwide Multidisciplinary Team Meetings for Autoimmune encephalitis, which are conducted on a bi-monthly basis. All patients with newly diagnosed NMDAR, LGI1, CASPR2, IgLON5, GFAP or GAD65 encephalitis and treated for less than 8 weeks will be included. Treatment protocols at the initiation of therapy will be stratified into: 1) first-line only; 2) rituximab without cyclophosphamide; 3) rituximab combined with cyclophosphamide; 4) others.
The referral clinicians will be contacted by email and the data will be collected using standardized questionnaires, which will be sent at baseline (visit 1, V1) and 4 months after the initiation of therapy (visit 2, V2). The questionnaires will be structured into 7 sections:
- 1 Demographics
- 2 Symptoms
- 3 Cognitive screening tests (MMSE, MoCA, and/or others)
- 4 Level of dependence (ADL, I-ADL, mRS, CASE) and impact on social life
- 5 Diagnostic tests (brain MRI, brain PET, CSF, and EEG findings)
| Study group | Role | What they receive |
|---|---|---|
| group 1 : Patients with NMDAR encephalitis | Patients with untreated anti-NMDAR encephalitis or with a decision to treat within the previous 30 days Receives: Other: We aim to assess the clinical response to the treatment initiation protocols most commonly used in autoimmune encephalitis (first-line, first-line with rituximab, dual immunosuppression). | |
| group 2 : Patients with GAD encephalitis | Patients with untreated anti-GAD encephalitis or with a decision to treat within the previous 30 days Receives: Other: We aim to assess the clinical response to the treatment initiation protocols most commonly used in autoimmune encephalitis (first-line, first-line with rituximab, dual immunosuppression). | |
| group 3 : Patients with LGI1 encephalitis | Patients with untreated anti-LGI1 encephalitis or with a decision to treat within the previous 30 days Receives: Other: We aim to assess the clinical response to the treatment initiation protocols most commonly used in autoimmune encephalitis (first-line, first-line with rituximab, dual immunosuppression). | |
| group 4 : Patients with IgLON5 encephalitis | Patients with untreated anti-IgLON5 encephalitis or with a decision to treat within the previous 30 days Receives: Other: We aim to assess the clinical response to the treatment initiation protocols most commonly used in autoimmune encephalitis (first-line, first-line with rituximab, dual immunosuppression). | |
| group 5 : Patients with GFAP encephalitis | Patients with untreated anti-GFAP encephalitis or with a decision to treat within the previous 30 days Receives: Other: We aim to assess the clinical response to the treatment initiation protocols most commonly used in autoimmune encephalitis (first-line, first-line with rituximab, dual immunosuppression). | |
| group 6 : Patients with CASPR2 encephalitis | Patients with untreated anti-CASPR2 encephalitis or with a decision to treat within the previous 30 days Receives: Other: We aim to assess the clinical response to the treatment initiation protocols most commonly used in autoimmune encephalitis (first-line, first-line with rituximab, dual immunosuppression). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure of the initial treatment protocol
Failure of the initial treatment protocol, reflected by the decision to escalate treatment between V1 and V2. Treatment escalation is defined as the addition of one or more second-line treatments more than 30 days after the start of the initial treatment.
Measured: At baseline and 4 months after the initiation of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start1 Sep 2024
- Primary completion1 Sep 2024
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NMDAR Autoimmune EncephalitisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07133113
- Sponsor's protocol ID
- 24-5346
- Acronym
- META
- Status last verified
- Mar 2025
- First submitted
- 13 Aug 2025
- Last updated
- 20 Aug 2025
- 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 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medium-term Effects of Treatments in Autoimmune Encephalitis (META): a Real-life, Observational Prospective Study
- ClinicalTrials.gov ID
- NCT07133113
- Acronym / sponsor ID
- META / 24-5346
- Conditions
- NMDAR Autoimmune Encephalitis, LGI1 Antibody Associated Encephalitis, CASPR2-Antibody, IgLON5, GAD65, GFAP
- Keywords
- Paraneoplastic neurological disorder, autoimmune encephalitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 20 Aug 2025 (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.
Autoimmune encephalitides are severe neurological disorders requiring urgent treatment, even though there is no standard guideline by lack of empirical evidence. Commonly used treatments are divided into so-called first-line (steroids, intravenous immunoglobulins, plasma exchanges) and second-line (rituximab, cyclophosphamide, tocilizumab, others), and may be used in association or sequentially. There is no standard practice, and initial treatment protocol may consist in first-line alone, first-line with rituximab, or first-line with dual immunosuppression (rituximab and cyclophosphamide). Absence of clear response to initial treatment in the first 4 to 6 weeks may indicate undertreatment and is generally followed by treatment escalation, mostly to dual immunosuppression. However, as the frequency of non-responders to initial treatment is unknown, it is still unclear whether dual immunosuppression should be offered to all patients from inception.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| group 1 : Patients with NMDAR encephalitis | – | Other: We aim to assess the clinical response to the treatment initiation protocols most commonly used in autoimmune encephalitis (first-line, first-line with rituximab, dual immunosuppression).Patients with untreated anti-NMDAR encephalitis or with a decision to treat within the previous 30 days |
| group 2 : Patients with GAD encephalitis | – | Other: We aim to assess the clinical response to the treatment initiation protocols most commonly used in autoimmune encephalitis (first-line, first-line with rituximab, dual immunosuppression).Patients with untreated anti-GAD encephalitis or with a decision to treat within the previous 30 days |
| group 3 : Patients with LGI1 encephalitis | – | Other: We aim to assess the clinical response to the treatment initiation protocols most commonly used in autoimmune encephalitis (first-line, first-line with rituximab, dual immunosuppression).Patients with untreated anti-LGI1 encephalitis or with a decision to treat within the previous 30 days |
| group 4 : Patients with IgLON5 encephalitis | – | Other: We aim to assess the clinical response to the treatment initiation protocols most commonly used in autoimmune encephalitis (first-line, first-line with rituximab, dual immunosuppression).Patients with untreated anti-IgLON5 encephalitis or with a decision to treat within the previous 30 days |
| group 5 : Patients with GFAP encephalitis | – | Other: We aim to assess the clinical response to the treatment initiation protocols most commonly used in autoimmune encephalitis (first-line, first-line with rituximab, dual immunosuppression).Patients with untreated anti-GFAP encephalitis or with a decision to treat within the previous 30 days |
| group 6 : Patients with CASPR2 encephalitis | – | Other: We aim to assess the clinical response to the treatment initiation protocols most commonly used in autoimmune encephalitis (first-line, first-line with rituximab, dual immunosuppression).Patients with untreated anti-CASPR2 encephalitis or with a decision to treat within the previous 30 days |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All Patients with autoimmune encephalitis defined anti-GAD NMDAR, LGI1, CASPR2, IgLON5 or GFAP and untreated within the previous 30 days
Key inclusion criteria (2 listed)
- Adult or child patient with encephalitis defined as anti-GAD, NMDAR, LGI1, CASPR2, IgLON5 or GFAP
- Untreated or with a decision to treat within the previous 30 days.
Key exclusion criteria (1 listed)
- Refusal by the referring doctor to participate or refusal by the patient mentioned in the objection to the use of his/her clinical data.
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 |
|---|---|---|
| We aim to assess the clinical response to the treatment initiation protocols most commonly used in autoimmune encephalitis (first-line, first-line with rituximab, dual immunosuppression).The patients will be identified via the French Nationwide Multidisciplinary Team Meetings for Autoimmune encephalitis, which are conducted on a bi-monthly basis. All patients with newly diagnosed NMDAR, LGI1, CASPR2, IgLON5, GFAP or GAD65 encephalitis and treated for less than 8 weeks will be included. Treatment protocols at the initiation of therapy will be stratified into: 1) first-line only; 2) rituximab without cyclophosphamide; 3) rituximab combined with cyclophosphamide; 4) others. The referral clinicians will be contacted by email and the data will be collected using standardized questionnaires, which will be sent at baseline (visit 1, V1) and 4 months after the initiation of therapy (visit 2, V2). The questionnaires will be structured into 7 sections: * 1 Demographics * 2 Symptoms * 3 Cognitive screening tests (MMSE, MoCA, and/or others) * 4 Level of dependence (ADL, I-ADL, mRS, CASE) and impact on social life * 5 Diagnostic tests (brain MRI, brain PET, CSF, and EEG findings) | Other | group 1 : Patients with NMDAR encephalitis, group 2 : Patients with GAD encephalitis, group 3 : Patients with LGI1 encephalitis, group 4 : Patients with IgLON5 encephalitis, group 5 : Patients with GFAP encephalitis, group 6 : Patients with CASPR2 encephalitis |
Primary outcome
Failure of the initial treatment protocol
Time frame: At baseline and 4 months after the initiation of therapy
Failure of the initial treatment protocol, reflected by the decision to escalate treatment between V1 and V2. Treatment escalation is defined as the addition of one or more second-line treatments more than 30 days after the start of the initial treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NMDAR Autoimmune Encephalitis and LGI1 Antibody Associated Encephalitis, run by Hospices Civils de Lyon 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 20 Aug 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bastien Pr JOUBERT (04 78 86 17 89, bastien.joubert@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure of the initial treatment protocol (time frame: At baseline and 4 months after the initiation of therapy). 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 20 Aug 2025.