Generalized Epilepsy
Conditions
Interventions
Test Group:Brivaracetam
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
8 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged 8 to 60 years (inclusive); 2. The patient and/or their legal guardian provides written informed consent to participate in the study; 3. Diagnosed with generalized epilepsy according to the 2017 ILAE classification of seizures and epilepsy, confirmed by electroencephalogram (EEG) findings; 4. Considered by the investigator to be suitable for adjunctive therapy with brivaracetam; 5. Dissatisfaction with the current efficacy or adverse drug reactions despite having received optimal dose and duration of either one anti-seizure medication (ASM, not levetiracetam) or multiple ASMs (which may include levetiracetam); 6. Currently receiving a stable dose of other anti-seizure medications for at least 4 weeks, yet still experiencing seizures with a frequency of at least 2 seizures per 3 months, and a minimum interval of 24 hours between seizures; 7. Willing and able to comply with the study protocol for the entire duration of the study.
Exclusion criteria
Exclusion criteria: 1. Positive pregnancy test, lactating women, or male participants (or their partners)/female participants planning a pregnancy during the trial or within 3 months after study completion, or unwilling to use one or more non-pharmacological contraceptive methods during the trial; 2. Known hypersensitivity to brivaracetam or any of its excipients, or a history of allergic predisposition; 3. History of drug abuse, alcohol abuse, substance abuse, or psychiatric illness; presence of a severe structural, genetic-metabolic etiology; or a definitive diagnosis of an epileptic encephalopathy; 4. Severe pulmonary, hematological diseases; uncontrolled cardiac disease; uncontrolled hypertension; malignancy; immunocompromised status; or psychiatric disorders; 5. Planned initiation of ketogenic diet therapy, epilepsy surgery (including vagus nerve stimulation), or transcranial magnetic stimulation in the near future; 6. Use of other drugs within 1 month prior to screening that may affect the absorption, distribution, metabolism, or excretion of the investigational product, such as antipsychotics, monoamine oxidase inhibitors, barbiturates (except those used concomitantly as anticonvulsant therapy), or narcotic analgesics; 7. Participation in another clinical trial within 3 months prior to screening; 8. Any other condition deemed by the investigator to make the patient unsuitable for participation in this trial;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate (ORR);Response Rate for Generalized Seizures;Incidence of Serious Adverse Events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Activities of Daily Living (ADL) Score;Seizure-free rate;Change in Quality of Life Score;Mean Seizure Reduction Rate;Final maintenance dose of BRV;Time to First Seizure;Change in Cognitive Function Score;Retention Rate; | — |
Countries
China
Contacts
Public ContactXunyi Wu
Huashan Hospital, Fudan University
Outcome results
None listed