Partial-onset epilepsy
Conditions
Interventions
Investigational drug group (single-arm study):The weight of the children to be included was stratified and divided into three dose groups, dose group A: body weight: >=50kg, the initial dose was 50mg-
Dose group B: body weight: 20kg<=body weight<50kg, starting dose 1~2mg/kg/day, maintenance dose 1~4mg/kg/day
Dose group C: body weight: 11kg<=body weight<20kg, starting dose 1-2.5mg/kg/day, maintenance dose 1-5mg/kg/day. Each dose group will be carried out sequentially in two phases, of which the first phase
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
2 Years to 16 Years
Inclusion criteria
Inclusion criteria: 1. At the time of signing the informed consent form, the age is >=2 years old to <16 years old; Male or female. 2. Diagnosed with partial-onset epilepsy according to the 2017 International League Against Epilepsy (ILAE) classification criteria for seizures and epilepsy. 3. At the time of screening, according to the judgment of the investigator, it is believed that the subject/caregiver is able to follow up and complete the study process and assessment as required by the protocol, including being able to understand and fill in the epilepsy diary card. 4. The subject has uncontrolled partial seizures at the time of screening, which is expected to benefit from this study according to the judgment of the investigator. 5. Subjects and their legal guardians agree to participate in the study and voluntarily sign the informed consent form, and are able to communicate well with the investigator.
Exclusion criteria
Exclusion criteria: 1. Subject has been previously treated with bripiracetam and the treatment has been discontinued due to lack of efficacy or due to adverse events. 2. 4 weeks before the first dose and during the trial, the subjects are receiving other trial drugs in addition to brimiracetam. 3. At the time of screening, the subject has a history of gastrointestinal diseases; 4. Subject has a history of allergy to 2 or more drugs. 5. Subject has other acute or subacute progressive central nervous system disease. 6. Subject has congenital heart disease at screening. 7. At screening, the subject's electrocardiogram was abnormal and clinically significant. 8. Status epilepticus within 4 weeks prior to subject screening. 9. Clinically significant acute or chronic diseases, underlying diseases. 10. The following laboratory test indicators or any other clinically relevant abnormal results during the screening period, which in the opinion of the investigator may put the subject at risk due to the subject's participation in the study. 11. Aminotransferase > 1.5 times the upper limit of normal; or >1.0xULN total bilirubin (TBil) (>=1.5xULN TBil if Gilbert's syndrome is known). 12.>=6-year-old subjects with a history of suicide attempt at screening 13. Subject is taking felbamate with continuous exposure for less than 18 months. 14. Subjects treated with vigabatrin with visual field defects. 15. Other investigators who are considered unsuitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment-emergent adverse events (TEAEs).;Incidence of study-drug-related serious adverse events (SAEs) occurring during the treatment period;Incidence of treatment-emergent important adverse events related to the study drug;Incidence of TEAEs occurring during treatment that lead to study drug discontinuation and are related to the study drug; | — |
Countries
China
Contacts
Public ContactJiang Yuwu
Peking University First Hospital
Outcome results
None listed