Autoimmune EncephalitisNCT05422664
Acute Sympotomatic Seizure Secondary to Autoimmune Encephalitis and Autoimmune-associated Epilepsy
An observational study of Autoimmune Encephalitis and Epilepsy, run by Liu Yonghong at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Autoimmune Encephalitis, Epilepsy, Seizures
- What is being tested?
- Lacosamide
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with confirmed autoimmune encephalitis
Who may be able to join
- 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;
Who cannot join
- Incomplete key clinical data;
- People with epilepsy or other intracranial diseases before diagnosis;
- There is no epileptic author during the onset of autoimmune encephalitis;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Autoimmune Encephalitis, Epilepsy, Seizures
- Being tested
- Lacosamide
- Medical subject headings
- Autoimmune Diseases of the Nervous System, Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LacosamideDrug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
seizures or epilepsy
Patients with autoimmune encephalitis have sympotmatic seizures in the acute phase,which develop into seizure-free or autoimmune-associated epilepsy.
Measured: 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.
Measured: 1 year after lacosamide addition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start1 Jan 2018
- Primary completion31 May 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune EncephalitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liu Yonghong
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital Xi'an Jiaotong University, Second Affiliated Hospital of Xi'an Jiaotong University, Xian Children's Hospital, Baoji Central Hospital, First Affiliated Hospital of Kunming Medical University, First Affiliated Hospital of Harbin Medical University, Qilu Children's Hospital of Shandong University
- Responsible party
- Sponsor-investigator, Liu Yonghong, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05422664
- Sponsor's protocol ID
- KY20222079-F-1
- Status last verified
- Jul 2023
- First submitted
- 13 Jun 2022
- Last updated
- 14 Jul 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Clinical Study of Acute Sympotomatic Seizure Secondary to Autoimmune Encephalitis and Autoimmune-associated Epilepsy
- ClinicalTrials.gov ID
- NCT05422664
- Acronym / sponsor ID
- KY20222079-F-1
- Conditions
- Autoimmune Encephalitis, Epilepsy, Seizures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Liu YonghongUniversity, hospital or other
- Collaborators
- First Affiliated Hospital Xi'an Jiaotong University, Second Affiliated Hospital of Xi'an Jiaotong University, Xian Children's Hospital, Baoji Central Hospital, First Affiliated Hospital of Kunming Medical University, First Affiliated Hospital of Harbin Medical University, Qilu Children's Hospital of Shandong University
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with confirmed autoimmune encephalitis
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (3 listed)
- Incomplete key clinical data;
- People with epilepsy or other intracranial diseases before diagnosis;
- There is no epileptic author during the onset of autoimmune encephalitis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LacosamidePatients 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. | Drug | – |
Primary outcome
seizures or epilepsy
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Encephalitis and Epilepsy, run by Liu Yonghong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
seizures or epilepsy (time frame: From admission to discharge, up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023.