Comparison of Oral Brivaracetam Versus Levetiracetam as Monotherapy in Epilepsy
- Registration Number
- NCT07163585
- Lead Sponsor
- RESnTEC, Institute of Research
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 102
- Children of either gender
- Aged 1 month to 14 years
- With a clinical diagnosis of newly diagnosed epilepsy
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Brivaracetam group Brivaracetam Patients were given oral brivaracetam in 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. Levetiracetam group Levetiracetam Oral 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.
- Primary Outcome Measures
Name Time Method Cessation of seizures Up to 3 months Cessation of seizures was labeled "yes" when a patient remained seizure free.
- Secondary Outcome Measures
Name Time Method Adverse events Up to 3 months Labeled "yes" if any treatment-related adverse events reported.
Trial Locations
- Locations (1)
The Children's Hospital and Institute of Child Health
🇵🇰Multan, Punjab Province, Pakistan
The Children's Hospital and Institute of Child Health🇵🇰Multan, Punjab Province, Pakistan