ClinicalTrials.gg
Not yet recruitingNCT06760091Updated Jan 6, 2025

A Multicentric Cohort of Autoimmune Encephalitis

An observational study in Autoimmune Encephalitis, sponsored by Xuanwu Hospital, Beijing. Not yet recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2025-01-06.

Sponsored by Xuanwu Hospital, Beijing · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 26 studies in Autoimmune Diseases of the Nervous System with a site in China — 18 open to participants now, 20 under way, 3 of them phase 3. Autoimmune Diseases of the Nervous System · China.

Planned enrollment
9th of 13
200 · median 300
Started
2025
with 3 others
Observational
13 of 26
9 open now
Primary completion
2028-12
later than 15 of 19 live
Registered
14th of 26
by date
Lead sponsor
3 of 26
Xuanwu Hospital, Beijing

Among the 26 studies in Autoimmune Diseases of the Nervous System with a site in China, this one is the 9th largest by planned enrollment of the 13 observational ones that give a count, is one of 4 that started in 2025, is one of 13 observational ones, reaches primary completion later than 15 of the 19 other live ones, and was the 14th registered.

Autoimmune Diseases of the Nervous System

123 studies on the registry are indexed under Autoimmune Diseases of the Nervous System; 59 are open to participants now.

Browse Autoimmune Diseases of the Nervous System studies →

Open to participants now

18 of the 26 studies in Autoimmune Diseases of the Nervous System with a site in China are open now. Recruiting first, the newest first:

12 more — sign in →

All 18 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 44 Autoimmune Diseases of the Nervous System studies recruiting now, 27 (61%) set no upper age limit and 11 (25%) stop at 75 or younger; 15 take children under 18; 9 take healthy volunteers.

This study: all sexes · no healthy volunteers.

The full table on the hub →

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02

Study 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 ). 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.

03

Conditions studied

  • Autoimmune Encephalitis
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with autoimmune encephalitis or paraneoplastic neurological syndrome will be enrolled and no additional exclusion criteria are set.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

    1. Gender and age are not limited; 2. Newly diagnosed encephalitis according to at least one of the following three criteria:

      1. According to the criteria of Graus et al in 2016, diagnosed as "definite autoimmune limbic encephalitis"
      2. 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
      3. 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 form.

Additional inclusion criteria for patients in the epilepsy subgroup: patients diagnosed with epilepsy secondary to autoimmune encephalitis.

Exclusion criteria

Exclusion Criteria:

  • No additional exclusion criteria
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • autoimmune encephalitis group

    Other: baseline data collection and follow-up

Interventions

  • Otherbaseline data collection and follow-up

    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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 3months, 6 months, 12months, 24months

Secondary outcomes

  1. Proportion of Subjects With Occurrence

    Time frame: 12 months, 24 months

  2. 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.

    Time frame: 3months, 6 months, 12months, 24months

  3. Changes of pathogenic antibody titers from baseline

    Time frame: 3months, 6 months, 12months, 24months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Feb 2025; primary completion for Dec 2028, 46 months later.

Of 28 observational studies under Autoimmune Diseases of the Nervous System, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 17. This study's planned 46 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 30, 2024
First posted
Jan 6, 2025
StartEst.
Feb 1, 2025
Primary completionEst.
Dec 31, 2028
CompletionEst.
Dec 31, 2028
Last update
Jan 6, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06760091
Responsible party
Sponsor
First posted
Jan 6, 2025
Start date
Feb 1, 2025 (estimated)
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Jan 6, 2025

Study contacts

Junwei Hao, MD; PhD
Contact
haojunwei@vip.163.com
01083198277

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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