Autoimmune EncephalitisNCT07036042
Clinical Characteristics of Patients With Anti-Collapsin Response Mediator Protein 2 Antibodies in Encephalitis or Encephalomyelitis
An observational study of Autoimmune Encephalitis, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Autoimmune encephalitis (AE) is an important autoimmune neurological disease, and its clinical manifestations, treatment and prognosis are closely related to the type of pathogenic antibodies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Encephalitis
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 31 Dec 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the Department of Neurology, Nanfang Hospital
The inclusion criteria for patients are illustrated: 1) patients admitted to the Department of Neurology,or the Neurocritical Unit (NCU) of Nanfang Hospital, Southern Medical University, between January 2017 and November 2019; 2) patients with suspected immune-mediated encephalopathy (altered consciousness persisting for more than 24 hours) or myelopathy. This included cases of encephalopathy suspected to be autoimmune, infectious or metabolic as well as encephalopathy with unclear etiology; 3) patients with remaining serum and/or cerebrospinal fluid (CSF) samples available for immunoreaction analysis using tissue-based assay (TBA) and cell-based assay (CBA). All samples were the first obtained from patients after hospitalization, prior to initiating treatment at our hospital. Some patients, however, may have received treatment at other hospitals before being transferred here.
The exclusion criteria were: 1) loss to follow-up; 2) incomplete data; 3) encephalopathy resulting from toxic, traumatic, anoxic/hypoxic, genetic, or endocrine causes.
Trial locations and contacts
1 site in 1 country.
About this study
Autoimmune encephalitis (AE) is an important autoimmune neurological disease, and its clinical manifestations, treatment and prognosis are closely related to the type of pathogenic antibodies. However, due to the limited antibody spectrum and the unclear pathogenic mechanism, the disease is difficult to diagnose and treat, and the morbidity and mortality rates are high. In a previous study, we found that anti-CRMP2 antibodies were AE-specific autoantibodies, adding a new member to the AE antibody spectrum and thus defining a new class of AEs, anti-CRMP2 encephalitis. However, due to the limited number of cases, its clinical characteristics such as incidence, concomitant diseases, imaging manifestations, treatment effects and prognosis are not yet clear. This study plans to conduct large-scale anti-CRMP2 antibody screening in critically ill patients with suspected neurological autoimmune diseases in our hospital, and compare the clinical differences between anti-CRMP2 encephalitis and other known AEs and non-autoimmune encephalitis.
- Conditions
- Autoimmune Encephalitis
- Medical subject headings
- Autoimmune Diseases of the Nervous System
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibodies CRMP2 detected in blood or cerebrospinal fluid
Measured: 2024.12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start1 Jun 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
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 Nanfang Hospital, Southern Medical UniversityThe 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
- Other
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036042
- Sponsor's protocol ID
- NFEC-2022-180
- Status last verified
- Jun 2025
- First submitted
- 17 Jun 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All participants' data are confidential.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics of Patients With Anti-Collapsin Response Mediator Protein 2 Antibodies in Encephalitis or Encephalomyelitis
- ClinicalTrials.gov ID
- NCT07036042
- Acronym / sponsor ID
- NFEC-2022-180
- Conditions
- Autoimmune Encephalitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 25 Jun 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 encephalitis (AE) is an important autoimmune neurological disease, and its clinical manifestations, treatment and prognosis are closely related to the type of pathogenic antibodies. However, due to the limited antibody spectrum and the unclear pathogenic mechanism, the disease is difficult to diagnose and treat, and the morbidity and mortality rates are high. In a previous study, we found that anti-CRMP2 antibodies were AE-specific autoantibodies, adding a new member to the AE antibody spectrum and thus defining a new class of AEs, anti-CRMP2 encephalitis. However, due to the limited number of cases, its clinical characteristics such as incidence, concomitant diseases, imaging manifestations, treatment effects and prognosis are not yet clear. This study plans to conduct large-scale anti-CRMP2 antibody screening in critically ill patients with suspected neurological autoimmune diseases in our hospital, and compare the clinical differences between anti-CRMP2 encephalitis and other known AEs and non-autoimmune encephalitis.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the Department of Neurology, Nanfang Hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Antibodies CRMP2 detected in blood or cerebrospinal fluid
Time frame: 2024.12
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 26 Jun 2025.
- Individual participant dataSharing planned: No. All participants' data are confidential.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Nanfang Hospital, Southern Medical University 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?
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 26 Jun 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?
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?
Antibodies CRMP2 detected in blood or cerebrospinal fluid (time frame: 2024.12). 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 26 Jun 2025; AzTrials last refreshed its copy on 8 Nov 2026.