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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05422664
Other study ID # KY20222079-F-1
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date December 31, 2025

Study information

Verified date July 2023
Source Xijing Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 500
Est. completion date December 31, 2025
Est. primary completion date May 31, 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
China XijingH Xi'an Shaanxi

Sponsors (8)

Lead Sponsor Collaborator
Liu Yonghong Baoji Central Hospital, First Affiliated Hospital of Harbin Medical University, First Affiliated Hospital of Kunming Medical University, First Affiliated Hospital Xi'an Jiaotong University, Qilu Children's Hospital of Shandong University, Second Affiliated Hospital of Xi'an Jiaotong University, Xian Children's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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