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

NCT05422664 | Unknown FDA Drug

• 1 other identifier: KY20222079-F-1
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

Lacosamide DRUG

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with confirmed autoimmune encephalitis

You may qualify if:

• 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;

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

XijingH

Xi'an, Shaanxi, 710000, China

Location

MeSH Terms

Conditions

Autoimmune Diseases of the Nervous System; Epilepsy; Seizures

Interventions

Lacosamide

Condition Hierarchy (Ancestors)

Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Brain Diseases; Central Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 16, 2022
• Study Start: January 1, 2018
• Primary Completion: May 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 14, 2023

Record last verified: 2023-07

Locations

CN (1)