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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06388161
Other study ID # Yan2022-0336
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2023
Est. completion date December 31, 2030

Study information

Verified date April 2024
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Chun-Hong Shen
Phone +86 0571 87783872
Email shen_neurology@zju.edu.cn
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Seizure is one of the most common symptoms in autoimmune encephalitis with neuronal surface-mediated antibodies. Interestingly, some patients may exhibit new-onset seizures as the initial manifestation without fulminant sign of encephalitis, particularly in the early stage. It is essential to recognize these patients early and to perform antibody testing, as studies have reported early immunotherapy can improve their clinical outcomes. At the same time, it is important to limit the number of patients who require testing, for the sake of specificity and cost effectiveness. Thus, this prospective, multicenter study aims to identify neural antibodies in patients with focal seizures of unknown etiology, and to create a score to preselect patients requiring autoantibody testing.


Description:

1. Focal epileptic seizure or epilepsy is defined according to seizure semiology, electroencephalography findings and/or other relevant information. If applicable, 24 hour video-electroencephalography is performed. 2. Clinical information is documented by specially-assigned persons, including patient demographics, age at onset, disease duration, seizure semiology, seizure frequency, clinical manifestations, underlying malignancy, hyponatremia, brain MRI, medications and other diseases. 3. The Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Hamilton Depression Scale (HAMA), Hamilton Anxiety Scale (HAMA) and the modified Rankin Scale (mRS) at baseline were assessed and recorded. 4. Previous scoring scales, such as antibody prevalence in epilepsy and encephalopathy (APE2) score, antibodies contributing to focal epilepsy signs symptoms (ACES) score and the "Obvious" Indications for Neural Antibody Testing in Epilepsy or Seizures (ONES) checklist are evaluated at baseline. 5. Commercial cell-based assay (CBA; EUROIMMUN, Lübeck, Germany) was used to detect serum anti-N-methyl-D-aspartate receptor (anti-NMDAR), anti-α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptor (anti-AMPAR), anti-γ-aminobutyric acid B receptor (anti-GABABR), anti-leucine-rich glioma-inactivated 1 (anti-LGI1), anti-contactin-associated protein-like 2 (anti-CASPR2), and anti-glutamic acid decarboxylase 65 (anti-GAD65), anti-metabotropic glutamate receptor 5 (mGluR5), anti-dipeptidyl peptidase-like protein 6 (DPPX), anti-myelin oligodendrocyte glycoprotein (MOG) and anti-immunoglobulin-like cell adhesion molecule 5 (IgLON5) antibodies. If serum neural autoantibodies are detected, cerebrospinal fluid should be tested.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date December 31, 2030
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 14 Years to 100 Years
Eligibility Inclusion Criteria: - Patients have a diagnosis of new-onset focal epileptic seizure or epilepsy and present with their first seizure within the previous 12 months - Patients are prospectively recruited from the routine practice of epileptologists in epilepsy centers and epilepsy clinics - There is no obvious suspicion of autoimmune encephalitis - Written informed consent and sera are obtained - Cerebrospinal fluid test must be conducted, when patients have detectable serum autoantibodies Exclusion Criteria: - Patients have other etiology of seizures, such as structure, infection, genetics and metabolism. - Written informed consent are not obtained - Loss of follow-up

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China Hangzhou Zhejiang

Sponsors (4)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University Ningbo Medical Center Lihuili Hospital, Shaoxing People's Hospital, Sir Run Run Shaw Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Detectable serum neural autoantibodies such as NMDAR?AMPAR1?AMPAR2?LGI1?lg LON5?DPPX?GAD65?mGluR5?MOG at baseline
Primary Neuronal surface antibodies-mediated autoimmune- encephalitis diagnosed according to the 2016 diagnostic criteria at baseline
Secondary The proportion of seizure freedom We defined seizure freedom according to the International League Against Epilepsy (ILAE) definition through study completion, an average of 1 year
Secondary The proportion of drug-resistent epilepsy We defined drug-resistent epilepsy according to the International League Against Epilepsy (ILAE) definition through study completion, an average of 1 year
Secondary Clinical severity and recovery modified Rankin scale, ranging from 0-6, higher scores mean a worse outcome through study completion, an average of 1 year
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