Autoimmune EncephalitisNCT06760091
A Multicentric Cohort of Autoimmune Encephalitis
An observational study of Autoimmune Encephalitis, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
This study aims to establish an autoimmune encephalitis cohort and observe the prognosis of patients with different subtypes and subgroups (e.g. epilepsy subgroup and teratoma subgroup ). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Autoimmune Encephalitis
- What is being tested?
- baseline data collection and follow-up
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2025to 31 Dec 2028
- 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: Patients with autoimmune encephalitis or paraneoplastic neurological syndrome will be enrolled and no additional exclusion criteria are set.
Who may be able to join
- 1. Gender and age are not limited; 2. Newly diagnosed autoimmune encephalitis according to at least one of the following three criteria:
- According to the criteria of Graus et al in 2016, diagnosed as "definite autoimmune limbic encephalitis"
- According to the criteria of Graus et al in 2016, diagnosed as "possible autoimmune encephalitis" and typical autoantibodies are detected in serum or cerebrospinal fluid
- According to the criteria of Graus et al in 2021, diagnosed as "possible or definite paraneoplastic neurological syndrome" (excluding peripheral nervous system syndrome) 3. The patient or legal representative voluntarily signed the paper informed consent form.
- Additional inclusion criteria for patients in the epilepsy subgroup: patients diagnosed with epilepsy secondary to autoimmune encephalitis.
Who cannot join
- No additional exclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xuanwu Hospital, Capital Medical University
Beijing
Junwei Hao, MD,PhD, 01083198277, haojunwei@vip.163.com
About this study
Official title: Multicentric Registry Study of Autoimmune Encephalitis
This study aims to establish an autoimmune encephalitis cohort and observe the prognosis of patients with different subtypes and subgroups (e.g. epilepsy subgroup and teratoma subgroup ). Clinical characteristics, biological samples, and imaging data will be collected to discover blood and imaging biomarkers for providing support for the treatment, early warning, and outcome prediction.
- Conditions
- Autoimmune Encephalitis
- Being tested
- baseline data collection and follow-up
- 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.
baseline data collection and follow-upOther
At the time of enrollment, baseline characteristics will be collected, and each subject will be followed up for 2 years through face-to-face, telephone, or online visits. During the follow-up period, the clinical prognosis will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| autoimmune encephalitis group | Not described Receives: Other: baseline data collection and follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in modified Rankin score (mRS) from baseline
Change in modified Rankin score (mRS) from baseline at month 1, month 3, month 6(mRS : Minimum Score 0, Maximum score 6, higher scores mean a worse outcome).
Measured: 3months, 6 months, 12months, 24months
Secondary outcomes (3)
Proportion of Subjects With Occurrence
Measured: 12 months, 24 months
Change of Clinical Assessment Scale in Autoimmune Encephalitis (CASE) Score from Baseline
The Clinical Assessment Scale in Autoimmune Encephalitis (CASE) score is designed specifically to assess the severity of autoimmune disease. It is a general scoring system ranging from 0 to 27 and can be used as an alternative tool to assess the severity of patients with AE more accurately. Higher scores mean a worse clinical status.
Measured: 3months, 6 months, 12months, 24months
Changes of pathogenic antibody titers from baseline
Measured: 3months, 6 months, 12months, 24months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune EncephalitisStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe 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
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06760091
- Sponsor's protocol ID
- XMEC-2024-003
- Status last verified
- Dec 2024
- First submitted
- 30 Dec 2024
- Last updated
- 6 Jan 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 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Registry Study of Autoimmune Encephalitis
- ClinicalTrials.gov ID
- NCT06760091
- Acronym / sponsor ID
- XMEC-2024-003
- Conditions
- Autoimmune Encephalitis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 6 Jan 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.
This study aims to establish an autoimmune encephalitis cohort and observe the prognosis of patients with different subtypes and subgroups (e.g. epilepsy subgroup and teratoma subgroup ). Clinical characteristics, biological samples, and imaging data will be collected to discover blood and imaging biomarkers for providing support for the treatment, early warning, and outcome prediction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| autoimmune encephalitis group | – | Other: baseline data collection and follow-up |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with autoimmune encephalitis or paraneoplastic neurological syndrome will be enrolled and no additional exclusion criteria are set.
Key inclusion criteria (5 listed)
- 1. Gender and age are not limited; 2. Newly diagnosed autoimmune encephalitis according to at least one of the following three criteria:
- Additional inclusion criteria for patients in the epilepsy subgroup: patients diagnosed with epilepsy secondary to autoimmune encephalitis.
Key exclusion criteria (1 listed)
- No additional exclusion criteria
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 |
|---|---|---|
| baseline data collection and follow-upAt the time of enrollment, baseline characteristics will be collected, and each subject will be followed up for 2 years through face-to-face, telephone, or online visits. During the follow-up period, the clinical prognosis will be recorded. | Other | autoimmune encephalitis group |
Primary outcome
Change in modified Rankin score (mRS) from baseline
Time frame: 3months, 6 months, 12months, 24months
Change in modified Rankin score (mRS) from baseline at month 1, month 3, month 6(mRS : Minimum Score 0, Maximum score 6, higher scores mean a worse outcome).
3 secondary outcomes
Proportion of Subjects With Occurrence
Time frame: 12 months, 24 months
Change of Clinical Assessment Scale in Autoimmune Encephalitis (CASE) Score from Baseline
Time frame: 3months, 6 months, 12months, 24months
Changes of pathogenic antibody titers from baseline
Time frame: 3months, 6 months, 12months, 24months
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 6 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Autoimmune Encephalitis
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
Natural History Study of Progressive Multifocal Leukoencephalopathy (PML)
Progressive Multifocal Leukoencephalopathy
RecruitingPhase 2
A Study in Participants With Anti-NMDAR Encephalitis and Anti-NMDAR Autoantibody-Associated Psychiatric Disease
Anti-N-methyl-D-aspartate Receptor (NMDAR) Encephalitis (ANRE), Anti-N-methyl-D-aspartate Receptor (NMDAR) Antibody-associated Psychiatric Disease
Not yet recruitingPhase 1/2
A Safety and Efficacy Study Evaluating CTX112 in Subjects With Refractory Neurologic Autoimmune Disease
Progressive Multiple Sclerosis (PMS), Neuromyelitis Optica
Recruiting
OPM- MEG in Non-immune And iMmune-medIated Neurological Disease
Autoimmune Encephalitis (AE), Acute Disseminated Encephalomyelitis
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 Autoimmune Encephalitis, run by Xuanwu Hospital, Beijing at 1 site in China.
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 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: opening soon, as of the sponsor's last update on 6 Jan 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 China. 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 Junwei Hao, MD; PhD (01083198277, haojunwei@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in modified Rankin score (mRS) from baseline (time frame: 3months, 6 months, 12months, 24months). 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 6 Jan 2025.