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

Sponsor

Liu Yonghong (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05422664

Collaborator

First Affiliated Hospital Xi'an Jiaotong University (Other), Second Affiliated Hospital of Xi'an Jiaotong University (Other), Xian Children's Hospital (Other), Baoji Central Hospital (Other), The First Affiliated Hospital of Kunming Medical College (Other), LanZhou University (Other), First Affiliated Hospital of Harbin Medical University (Other), Qilu Children's Hospital of Shandong University (Other)

500

Enrollment

Location

Anticipated Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autoimmune Encephalitis Epilepsy Seizures	Drug: Lacosamide

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Case-Only

Time Perspective:

Other

Official Title:

A Multicenter Clinical Study of Acute Sympotomatic Seizure Secondary to Autoimmune Encephalitis and Autoimmune-associated Epilepsy

Actual Study Start Date :

Jan 1, 2018

Anticipated Primary Completion Date :

May 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Outcome Measures

Primary Outcome Measures

seizures or epilepsy [From admission to discharge, up to 5 years]
Patients with autoimmune encephalitis have sympotmatic seizures in the acute phase,which develop into seizure-free or autoimmune-associated epilepsy.
seizure-free or others [1 year after lacosamide addition]
After obtaining informed consent, patients who eventually developed autoimmune epilepsy were given oral antiepileptic therapy with lacosamide according to their body weight, and the remission of seizures was observed.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Confirmed autoimmune encephalitis (2016,Lancet);
Meet the classification criteria for epilepsy (2017,International League Against Epilepsy);
Patients who still have seizures after taking ASM after the control of AE disease were included in the third part of the study;
All patients volunteered and signed an informed consent form;

Exclusion Criteria:

Incomplete key clinical data;
People with epilepsy or other intracranial diseases before diagnosis;
There is no epileptic author during the onset of autoimmune encephalitis;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	XijingH	Xi'an	Shaanxi	China	710000

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Liu Yonghong, professor, Xijing Hospital

ClinicalTrials.gov Identifier:

NCT05422664

Other Study ID Numbers:

KY20222079-F-1

First Posted:

Jun 16, 2022

Last Update Posted:

Jun 24, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 24, 2022