Stroke is the most serious disease endangering human health. Stroke is one of the most common causes of epilepsy in adulthood. The incidence of post-stroke epilepsy (PSE) is 3.1%-28.7%. Based on the time of onset after stroke, it can be divided into early PSE (onset 7 days after stroke).
Conditions
Interventions
Brivaracetam Treatment Group:Brivaracetam 100mg/day (50mg, po, bid) maintenance for 12 weeks
reduced to 50mg/day (25mg, po, bid) in week 13
Placebo Control Group:Placebo 100mg/day (50mg, po, bid) maintenance for 12 weeks
Sponsors
The First Affiliated Hospital,Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. No gender restriction, age >= 18 years old; 2. Acute stroke patients with a SeLECT-EEG score of >=7 and supported by imaging evidence (CT/MRI); 3. Acute ischemic stroke treated with thrombolytic therapy; 4. The mRS score was <=3 before the onset of this stroke; 5. The patient/legal guardian must agree to participate in this study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. The patient had a history of ischemic or hemorrhagic stroke within 12 months prior to this stroke; 2. The presence of significant risk factors for epilepsy that are not related to stroke, such as: a previous diagnosis of epilepsy, the presence of other epileptogenic intracranial lesions, or a history of intracranial surgery; 3. Pregnant or breastfeeding patients; 4. Those who are allergic to or have allergic constitution to BRV or any of its ingredients; 5. History of drug abuse, alcoholism, other substance abuse, and mental illness; 6. Patients with severe lung or hematological diseases, malignant tumors, or weakened immune function; 7. Those who participated in other clinical studies within the three months prior to screening; 8. Patients with migraine, trigeminal neuralgia, diabetic peripheral neuropathy, postherpetic neuralgia, myoclonus, restless legs syndrome, multiple sclerosis, or other conditions requiring anti-flare medications such as carbamazepine, oxcarbazepine, gabapentin, sodium valproate, levetiracetam, and pregabalin upon enrollment must be taking anti-flare medications at the time of enrollment. 9. Those deemed unsuitable to participate in this trial by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Individual epileptic seizure frequency at 12 months of follow-up; | — |
Secondary
| Measure | Time frame |
|---|---|
| Individual epileptic seizure frequency at 3, 6, 18 and 24 months of follow-up;Time to first symptomatic seizure after randomization treatment; overall survival.;Compare the frequency of the first occurrence of PSE within 6,24 months of follow-up in the BRV treatment group and the placebo group.;The BRV treatment group and the placebo group were compared at 6 and 24 months of follow-up, with mRS scores, Barthel Index, Montreal Cognitive Assessment (MoCA), Mini-Mental State Examination (MMSE),;Compare the differences in EEG characteristics between groups.;The incidence of serious adverse reactions is expressed as frequency (composition ratio).;Plasma Concentrations of Brivaracetam and Antiplatelet/Lipid-Lowering Drugs;Epileptogenic Network; | — |
Countries
China
Contacts
Public ContactChen Ziyi
The First Affiliated Hospital,Sun Yat-sen University
Outcome results
None listed