An observational study in Epilepsy and Status Epilepticus, sponsored by Second Affiliated Hospital of Guangzhou Medical University. Not yet recruiting at 1 site in China. Open to participants aged 4 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-05-30.
Sponsored by Second Affiliated Hospital of Guangzhou Medical University · Observational
Status epilepticus (SE) is an acute and critical form of neurological and systemic diseases involving multiple clinical disciplines, with an annual incidence of (20-73) per 100,000 people and a clinical case fatality rate of 20%. Although there are many causes of SE, the primary goal of treatment is to terminate the seizures quickly, and timely and standardized treatment can reduce mortality and improve prognosis. The prognosis is closely related to the duration of the episode, and the longer the episode, the worse the prognosis. If seizures of convulsive status epilepticus persist for more than 10 minutes and are not provided with optimal therapeutic intervention, serious adverse outcomes and even death are likely to occur. How to effectively terminate status epilepticus and actively find effective, reliable and safe treatment options is a key research problem at present. Due to critical illness, limited treatment options, and poor prognosis, new treatments are urgently needed to terminate persistent epileptic activity.
Lacosamide (LCM) is a third-generation new antiepileptic drug, which was approved in 2008 for the additive treatment of patients aged 16 years and older with focal seizures, with or without generalized seizures. In 2017, it was extended to patients over 4 years of age. Lacosamide is an anticonvulsant drug with a new dual mechanism of action: first, lacosamide antagonizes the glycine site of N-methyl-D-aspartate (NMDA) receptor; Second, lacosamide selectively acts on the slow inactivation of sodium channels and prolongs the inactivation time of sodium channels, which can more effectively reduce sodium influx and reduce the excitability of neurons, so as to achieve the purpose of treating epilepsy. Lacosamide exhibits linear pharmacokinetics, high oral bioavailability, protein binding of \< 15%, rapid and almost complete absorption in a single oral dose, and maximum plasma concentrations within 1 to 4 hours. A number of randomized controlled clinical studies and real-world studies abroad have shown that lacosamide can significantly improve the effective rate and seizure-free rate of epilepsy control, and it is well tolerated and has fewer adverse reactions. The 2022 Chinese Expert Consensus on the Diagnosis and Treatment of Post-stroke Epilepsy recommended lacosamide injection as a first-line drug for non-convulsive status epilepticus after stroke, and the Chinese Expert Consensus on the Diagnosis and Treatment of Status Epilepticus in Children (2022) recommended that lacosamide be considered as an additive treatment for refractory convulsive status epilepticus in children > 60 minutes . There is a lack of clinical research data on the efficacy and safety of intravenous bolus lacosamide for status epilepticus, including convulsive status epilepticus and non-convulsive epilepticus.
In this study, 100 patients with status epilepticus are to be treated. Patients and/or family members signed an informed consent form, and after screening, the participants are enrolled in the group and treated with intravenous lacosamide. The investigators are going to to evaluate the efficacy and safety of intravenous lacosamide in status epilepticus, and to observe the tolerability and adverse effects of lacosamide by observing the seizures and electroencephalogram changes of lacosamide after treatment with lacosamide. All treatments are performed in strict accordance with Good Clinical Practice for Drugs.
1,848 studies on the registry are indexed under Epilepsy; 422 are open to participants now.
This study's planned enrollment of 100 is below the median of 112 across 540 observational studies indexed under Epilepsy.
Browse Epilepsy studies →Second Affiliated Hospital of Guangzhou Medical University is the lead sponsor of 74 studies on the registry; 53 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with status epilepticus who are admitted to our hospital and other 4 collaboration hospitals
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
(1) Tonic-clonic seizures or convulsive seizures, lasting > 5min; (2) Between 2 or more seizures, consciousness is not restored; (3) Focal seizures with impaired consciousness, lasting >10min; (4) absence seizures, lasting >15min; 3. of the patient and signed a written consent form.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with status epilepticus meets the 2015 diagnostic criteria of the International League Against Epilepsy, which is a state in which seizures are persistent and likely to cause long-term impairment, and manifests as: 1. Tonic-clonic seizures or convulsive seizures, lasting \> 5min; 2. Between 2 or more seizures, consciousness is not restored; 3. Focal seizures with impaired consciousness, lasting \>10min; 4. absence seizures, lasting \> 15min;
Drug: Lacosamide (LCM)
Intravenous lacosamide is given for the treatment of seizure termination in patients with status epilepticus
Seizure reduction rate
1. 1-hour status epilepticus termination rate after treatment; 2. seizure-free rate 24 hours after treatment; 3. 3 day seizure-free rate after treatment.
Time frame: From enrollment to the end of treatment at 1 week
Plan to share: Yes — the efficacy of intravenous lacosamide in the treatment of seizure termination and electroencephalogram improvement in patients with status epilepticus
Start is estimated for Jun 2025; primary completion for Apr 2027, 22 months later.
Of 193 non-industry observational studies under Epilepsy, half reached primary completion within 62 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 179. This study's planned 22 months is below that.
Counting every sponsor, half of 230 studies reached it within 59 months; a quarter within 24 and three quarters within 119.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital of Guangzhou Medical University