Focal Epilepsy
Conditions
Interventions
Experimental group:Brivaracetam
Sponsors
Beijing Children's Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
14 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Gender is not limited, age 14~60 years old (including boundary value), of which Beijing Children's Hospital affiliated to Capital Medical University only enrolls adolescents aged 14~18 years old (including boundary value); 2. The patient/legal guardian agrees to participate in the study and signs the informed consent form; 3. According to the 2017 International League Against Epilepsy (ILAE) classification criteria for seizures and epilepsy, diagnosed with focal seizures or focal progression to bilateral tonic-clonic seizures, and confirmed by electroencephalogram results; 4. Suitable for brimiracetam monotherapy as judged by the doctor; 5. The number of focal seizures in the 3 months prior to enrollment ? 3 times.
Exclusion criteria
Exclusion criteria: 1. Women with a positive pregnancy test or breastfeeding, as well as male subjects (or their partners) or female subjects who have pregnancy plans throughout the trial period and within 3 months after the end of the study, or who are unwilling to take one or more non-drug contraceptive measures (such as complete abstinence, contraceptive ring, partner ligation, etc.) during the trial (see Annex 5 for specific contraceptive measures); 2. Those who are allergic or allergic to brivaracetam or any of its ingredients; 3. History of drug abuse, alcoholism, other substance abuse and mental illness; 4. Presence of severe structural, hereditary and metabolic causes or a clear diagnosis of epileptic encephalopathy; 5. Patients with severe pulmonary and hematologic diseases, malignant tumors, immunocompromised and mental illness; 6. Those who plan to undergo ketogenic diet, epilepsy surgery (including vagus nerve stimulation), or transcranial magnetic stimulation in the near future; 7. Use of other drugs that may affect the absorption, distribution, metabolism and excretion of this product within 1 month before entering the screening period, such as antipsychotic drugs, monoamine oxidase inhibitors, barbiturates (except for concomitant use as anticonvulsant treatment), narcotic analgesics; 8. Those who have participated in other clinical studies within 3 months before screening; 9. Those who are considered unsuitable to participate in this trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Epilepsy control efficiency; | — |
Countries
China
Contacts
Public ContactLiang Shuli
Beijing Children's Hospital Affiliated to Capital Medical University
Outcome results
None listed