Status:
NOT_YET_RECRUITING
Lacosamide Intravenous Injection for Emergency Termination of Status Epilepticus
Lead Sponsor:
Second Affiliated Hospital of Guangzhou Medical University
Collaborating Sponsors:
First Affiliated Hospital of Jinan University
Guangzhou First People's Hospital
Conditions:
Epilepsy
Status Epilepticus
Eligibility:
All Genders
4-60 years
Brief Summary
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 clinic...
Detailed Description
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 a...
Eligibility Criteria
Inclusion
- Age 4-60 years old, gender is not limited;
- Status epilepticus meets the 2015 diagnostic criteria of the International League Against Epilepsy, i.e., a state of persistent seizures that may cause long-term impairment and manifests itself 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; 3. Informed consent of the patient and signed a written consent form.
Exclusion
- Unstable vital signs;
- Electrocardiogram showing atrial flutter, atrial fibrillation, second-degree, third-degree atrioventricular block;
- History of allergy to the drugs used this time;
- Participants have a known history of past or present illness of non-epileptic seizures, and current seizures cannot be judged as status epilepticus based on symptomatology and/or electroencephalogram;
- Other patients who are considered by the investigator to be unsuitable to participate in the study;
- Incomplete clinical data or follow-up information
Key Trial Info
Start Date :
June 6 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 30 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06966830
Start Date
June 6 2025
End Date
October 30 2027
Last Update
May 30 2025
Active Locations (1)
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1
The Second Affiliated Hospital of Guangzhou Medical Universty
Guangzhou, GuanDong, China, 510260