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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Epilepsy; Seizures; Autoimmune Encephalitis
• Intervention / Treatment: Drug: Lacosamide

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710000
      • XijingH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with confirmed autoimmune encephalitis

Description

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;

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
seizures or epilepsy	Patients with autoimmune encephalitis have sympotmatic seizures in the acute phase,which develop into seizure-free or autoimmune-associated epilepsy.	From admission to discharge, up to 5 years
seizure-free or others	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.	1 year after lacosamide addition

Collaborators and Investigators

• Sponsor: Liu Yonghong
• Collaborators: First Affiliated Hospital Xi'an Jiaotong University; Second Affiliated Hospital of Xi'an Jiaotong University; First Affiliated Hospital of Harbin Medical University; Baoji Central Hospital; Xian Children's Hospital; Qilu Children's Hospital of Shandong University; First Affiliated Hospital of Kunming Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 13, 2022
• First Submitted That Met QC Criteria: June 13, 2022
• First Posted (Actual): June 16, 2022

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 11, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Immune System Diseases; Autoimmune Diseases; Neurologic Manifestations; Endocrine System Diseases; Thyroid Diseases; Thyroiditis, Autoimmune; Thyroiditis; Neuroinflammatory Diseases; Epilepsy; Encephalitis; Seizures; Autoimmune Diseases of the Nervous System; Hashimoto Disease; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lacosamide
• Other Study ID Numbers: KY20222079-F-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No