Comparison of Oral Brivaracetam Versus Levetiracetam as Monotherapy in Epilepsy

NCT07163585 | Completed

• 1 other identifier: Dr-Ikram-CH-Multan
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

• Cessation of seizures

  Cessation of seizures was labeled "yes" when a patient remained seizure free.

  Up to 3 months

Secondary Outcomes (1)

• Adverse events

  Up to 3 months

Study Arms (2)

Brivaracetam group

EXPERIMENTAL

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.

Drug: Brivaracetam

Levetiracetam group

EXPERIMENTAL

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.

Drug: Levetiracetam

Interventions

Brivaracetam DRUG

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.

Brivaracetam group

Levetiracetam DRUG

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.

Levetiracetam group

Eligibility Criteria

• Age: 1 Month - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children of either gender
• Aged 1 month to 14 years
• With a clinical diagnosis of newly diagnosed epilepsy

You may not qualify if:

• 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

Sponsors & Collaborators

• RESnTEC, Institute of Research: lead

Study Sites (1)

The Children's Hospital and Institute of Child Health

Multan, Punjab Province, 66000, Pakistan

Location

MeSH Terms

Conditions

Epilepsy

Interventions

brivaracetam; Levetiracetam

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ikram Rahman

  Children's Hospital and institute of Child Health Multan, Pakistan

  PRINCIPAL INVESTIGATOR

• Nuzhat Rahman, FCPS

  Children's Hospital and institute of Child Health Multan, Pakistan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Consultant

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 9, 2025
• Study Start: August 1, 2024
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: September 9, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)