Comparison of Oral Brivaracetam Versus Levetiracetam as Monotherapy in Epilepsy

RESnTEC, Institute of Research

Status: Completed

Conditions: Epilepsy

Treatments: Drug: Brivaracetam; Drug: Levetiracetam

Study type: Interventional

Funder types: Other

Identifiers

NCT07163585

Dr-Ikram-CH-Multan

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 1 month to 14 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

Brivaracetam group

Experimental group

Description:

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.

Treatment:

Drug: Brivaracetam

Levetiracetam group

Experimental group

Description:

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.

Treatment:

Drug: Levetiracetam