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A Prospective Study on the Efficacy and Safety of Brivaracetam in the Treatment of Childhood Epilepsy

A Prospective Study on the Efficacy and Safety of Brivaracetam in the Treatment of Childhood Epilepsy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111093
Enrollment
Unknown
Registered
2025-10-24
Start date
2025-10-24
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Interventions

Trial group:For BRV treatment, the initial doses for patients weighing 50 kg are 1.5–3 mg/kg/day, 1–2.5 mg/kg/day, 1–2 mg/kg/day, and 50–100 mg/day, respectively. Doses should be adjusted based on cli

Sponsors

Capital Children's Medical Center, Capital Medical University (Formerly known as the Capital Institute of Pediatrics)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Subjects aged >4 years, regardless of gender; 2. Children meet the 2017 International League Against Epilepsy (ILAE) diagnostic criteria for epilepsy based on clinical history and/or electroencephalogram; 3. Evaluated by at least two physicians and one pharmacist as requiring addition of BRV; 4. Seizure frequency >2 times per month, with inter-seizure intervals >24 hours; 5. Signed informed consent and voluntarily participating in the study.

Exclusion criteria

Exclusion criteria: 1.Patients taking antipsychotic drugs such as chlorpromazine, haloperidol, olanzapine, and risperidone, or those with mental illnesses such as schizophrenia, bipolar disorder, and depressive disorder; 2.Patients allergic to brivaracetam or pyrrolidone derivatives; 3.Patients currently being treated with levetiracetam; 4.Patients with symptomatic epilepsy caused by infectious, immune, or metabolic etiologies who are undergoing etiological treatment; 5.Patients with progressive neurological diseases, including degenerative central nervous system diseases and central nervous system tumors.

Design outcomes

Primary

MeasureTime frame
50% Response Rate;

Secondary

MeasureTime frame
Seizure-Free Rate;Retention Rate;Adverse Event Incidence Rate;Quality of Life;Cognitive Function Score;

Countries

China

Contacts

Public ContactJi Xinna

Capital Children's Medical Center, Capital Medical University (Formerly known as the Capital Institute of Pediatrics)

jina1227@163.com+86 136 9921 6061

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026