Epilepsy
Conditions
Brief summary
Despite increasing clinical use of both agents, there is a paucity of head-to-head comparative data on the safety and efficacy of brivaracetam versus levetiracetam as initial monotherapy in children. The present study was therefore designed to compare the safety and efficacy of oral brivaracetam and levetiracetam as monotherapy in children aged one month to 14 years with newly diagnosed epilepsy.
Detailed description
Most existing studies have focused on adjunctive use or refractory epilepsy, while evidence in treatment-naïve pediatric populations remains sparse. Addressing this gap is critical, as early and effective seizure control can substantially influence long-term neurodevelopmental outcomes. By evaluating seizure outcomes, tolerability, and adverse effect profiles, this study aims to provide evidence to guide clinicians in selecting the most appropriate first-line anti-seizure medication (ASM) for pediatric patients.
Interventions
DRUGBrivaracetam
Brivaracetam was initiated at a dose of 1-2 mg/kg/day in two divided doses, titrated to a maximum of 5 mg/kg/day based on clinical response and tolerability.
DRUGLevetiracetam
Levetiracetam was initiated at a dose of 10-20 mg/kg/day in two divided doses, with gradual escalation up to 60 mg/kg/day if needed.
Sponsors
RESnTEC, Institute of Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 14 Years
Healthy volunteers
No
Inclusion criteria
* Children of either gender * Aged 1 month to 14 years * With a clinical diagnosis of newly diagnosed epilepsy
Exclusion criteria
* History of prior use of long-term antiseizure medications * Evidence of progressive neurological disease * Metabolic abnormalities * Structural brain malformations * Incompatible with monotherapy * Severe systemic comorbidities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cessation of seizures | Up to 3 months | Cessation of seizures was labeled yes when a patient remained seizure free. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Up to 3 months | Labeled yes if any treatment-related adverse events reported. |
Countries
Pakistan
Outcome results
None listed