Acute Sympotomatic Seizure Secondary to Autoimmune Encephalitis and Autoimmune-associated Epilepsy

NCT ID: NCT05422664

Last Updated: 2023-07-14

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2025-12-31

Brief Summary

Previously, scholars called the seizures secondary to autoimmune encephalitis（AE） "autoimmune related epilepsy", but the seizures secondary to AE are usually controlled after the improvement of encephalitis, which does not meet the "persistent" characteristics of epilepsy. Only a subset of patients with seizures lasting several years require long-term Antiseizure medications (ASM). In 2020, the International Coalition against Epilepsy classified it as "acute symptomatic seizure secondary to AE". ASSAE) and autoimmune-associated epilepsy (AAE) . The former is caused by AE, which has clinical manifestations of AE at the same time as epileptic seizures at the beginning or recurrence. The proportion and type of epileptic seizures are different due to different causes, and epileptic seizures are also controlled after the disease is controlled. The latter is that after adequate immunotherapy, there are still persistent seizures, and there is no obvious evidence of inflammatory activity, this type of patient application ASM and immunotherapy is not effective.

Secondly, with the deepening of AE research, gradually found that some AAE can still be ASMs cure, such as carbamazepine, ocasepine, lakaosamine. On the one hand, it works by influencing cellular and humoral immune responses. On the other hand, effectiveness of sodium channel blockers in focal epilepsy. Lacosamide is a slow sodium channel blocker that belongs to the third generation of ASM. It has a short half-life and can be quickly increased to an effective dose with a low incidence of adverse reactions. Therefore, the investigators chose to add oral antiepileptic therapy with lacosamide in AAE populations to observe efficacy and safety.

Conditions

Autoimmune Encephalitis; Epilepsy; Seizures

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: OTHER

Interventions

Lacosamide

Patients with autoimmune related epilepsy were included. After obtaining informed consent, lacosamide was given according to the weight of the patients, and the efficacy and safety were observed.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Confirmed autoimmune encephalitis (2016,Lancet);

2. Meet the classification criteria for epilepsy (2017,International League Against Epilepsy);

3. Patients who still have seizures after taking ASM after the control of AE disease were included in the third part of the study;

4. All patients volunteered and signed an informed consent form;

Exclusion Criteria

1. Incomplete key clinical data;

2. People with epilepsy or other intracranial diseases before diagnosis;

3. There is no epileptic author during the onset of autoimmune encephalitis;

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital of Xi'an Jiaotong University

OTHER

Sponsor Role: collaborator

Xian Children's Hospital

OTHER_GOV

Sponsor Role: collaborator

Baoji Central Hospital

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Kunming Medical University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role: collaborator

Qilu Children's Hospital of Shandong University

OTHER

Sponsor Role: collaborator

Liu Yonghong

OTHER

Sponsor Role: lead

Responsible Party

Liu Yonghong

professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

XijingH

Xi'an, Shaanxi, China

Countries

China

Other Identifiers

KY20222079-F-1

Identifier Type: -

Identifier Source: org_study_id