Focal Epilepsy
Conditions
Interventions
Experimental group:Brivaracetam Tablet
Control group:Placebo
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
16 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily enrolled in this study and signed an informed consent form; 2. The age of the subject is between 16 and 80 years old (inclusive), regardless of gender; 3. The subject/guardian is reliable and able to comply with the study protocol (e.g., has the ability to understand and complete diaries), visit schedule, and medication,as determined by the investigator; 4. Diagnosed with epilepsy, diagnosed >= 6 months ago, and meets the criteria for focal seizures or focaltobilateral tonic-clonic seizures in the 2017 edition of the International League Against Epilepsy (ILAE) classification of seizures; 5. Subjects had an electroencephalogram (EEG) consistent with a diagnosis of focal seizures within the past 2 years (EEG is only used as a secondary diagnosis and is not mandatory for each subject); 6. A magnetic resonance imaging (MRI)/computed tomography (CT) scan of the brain within the past 2 years and consistent with a diagnosis related to focal seizures. If previous CT scan or MRI results within the past 2 years are not available, a CT scan or MRI must be performed and results received prior to Visit 2; 7. Subjects had at least 8 focal seizures during the 8-week baseline period and at least 2 focal seizures in each 4-weeks during the baseline period and were ‘seizure free’ for a period of no longer than 21 days; 8. Patients with focal seizures epilepsy uncontrolled on stable doses of 1-2 antiepileptic drugs (AEDs)(for phenobarbital, phenytoin, and primidone for at least 12 weeks with at stable doses) for at least 4 weeks prior to screening; 9. The therapeutic dose of AEDs and VNS (counting the VNS as a concomitant AED and completing implantation at least 6 months prior to dosing) permitted to be combined remained stable from at least 4 weeks prior to screening (for phenobarbital, phenytoin, and primidone at least 12 weeks with at stable doses) and were expected to remain stable throughout the duration of the study. Benzodiazepine use (for any indication) more than once per week will be considered concomitant AED; 10. Subjects who agree to use appropriate and effective contraception with their partner throughout the study and for 30 days after the last dose.
Exclusion criteria
Exclusion criteria: 1. Those who are currently receiving brivaracetam or levetiracetam (LEV) treatment or have used levetiracetam or brivaracetam within 12 weeks before screening; 2. Those who have used or are currently using traditional Chinese medicine or antiepileptic drugs containing traditional Chinese medicine ingredients within 4 weeks prior to screening; 3. Those who are known to have allergic reactions to brivaracetam or any inactive ingredients in the study drug; or those who are known to have a history of allergic diseases or severe drug allergies; 4. Those with only focal non-motor onset (2017 ILAE classification); 5. Subjects who have had suicidal behavior (suicide attempts, suicide interruptions, suicide abandonment, actions or behaviors to prepare for suicide, suicidal behavior) or suicidal ideation within 6 months before screening (answered 'yes' to question 4 or question 5 of 'suicidal ideation' in the Columbia Suicide Severity Rating Scale (C-SSRS); or the researcher believes that the subject has a serious risk of suicide; 6. Participated in a clinical study of any drug or medical device within 3 months prior to screening and used a clinical trial drug, medical device, or other clinical investigator who planned to participate during the study; 7. Subjects with a history of severe adverse hematological reactions to any drug; 8. Subjects with abnormal laboratory test indicators that are clinically significant as determined by the investigator: calculated CrCL 2ULN or/and GGT >3 ULN; 9. Subjects with any medical or mental condition that the investigator believes may endanger the subject or affect the subject's ability to participate in this study; 10. Subjects with a history of status epilepticus within one year before screening or during the baseline period; 11. Subjects with a history of frequent epileptic seizures that could not be accurately counted within one year before screening or during the baseline period; 12. Subjects with a current or past history of non-epileptic seizures; 13. Subjects with a history of cerebrovascular accident within 6 months before screening, such as cerebral infarction, cerebral hemorrhage, or transient ischemic attack; 14. Subjects who have used vigabatrin within 24 weeks prior to screening or subjects who have stopped using vigabatrin 24 weeks prior to screening but have no visual field test report (including standard static (Humphrey or Octopus) or dynamic visual field test (Goldman)), or these test results are abnormal; 15. Subjects are using any medication that may have central nervous system (CNS) effects unless it has been stable for at least 4 weeks before screening and is expected to remain stable throughout the study; 16. Subjects are using any drug that can significantly affect the metabolism of brivaracetam (potent inducers of cytochrome P450, such as rifampicin), unless it has been stable from at least 4 weeks before screening and is expected to remain stable throughout the study period remain stable within; 17. Subjects are known to have alcohol or drug addiction or abuse in the past 2 years (daily intake of alcohol, women more than 15 g [equivalent to 450 ml of beer, 150 ml of wine and yellow wine, or 50 ml of low-grade (<= 40 degrees) liquor], men more than 25 g [equivalent to 750 ml of beer, 250 ml of wine and yellow wine, or 85 ml of low-grade (<= 40 degrees) liquor], more than 2 days pe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage reduction in focal seizure frequency per 28 days of double-blind treatment period compared with placebo; | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate;Classification of the percentage reduction in the frequency of focal seizures from baseline during the double-blind treatment period;There was no seizure rate; | — |
Countries
China
Contacts
Public ContactWang Qun
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed