A Study to Investigate the Safety of the Drugs Topiramate and Levetiracetam in Treating Children Recently Diagnosed With Epilepsy

This is a randomized (study medication assigned to participants by chance), open-label,
multi-centric (conducted in more than one center) and 2-arm flexible-dose monotherapy study
of topiramate compared with 1 another AED (levetiracetam) in pediatric participants with
epilepsy. The total study duration will be up to of 1 year and 2 months per participant. The
study consists of 3 parts: Screening (that is, up to 35 days before study commences on Day
1); Treatment (1 year) and post-treatment (30 days). Safety will primarily be evaluated by
percentage of participants with kidney stones and change from baseline in bone mineral
density at Month 12.

Inclusion Criteria:

- Participant with a clinical diagnosis of new-onset or recent-onset epilepsy
characterized by partial-onset seizures (POS) (with or without secondary
generalization) or primary generalized tonic-clonic seizures (PGTCS) in accordance
with criteria of the International League Against Epilepsy. The epilepsy diagnosis
must be within the previous 2 years before screening

- Caregivers (parents or legally acceptable representatives) of the participant must be
able to accurately maintain the participant take-home record and seizure diary

- At screening, participant must have weight and height values within the 5th to 95th
percentile for chronological age (based on standard Child Height and Weight Charts
from the Centers for Disease Control [CDC])

- Participant must never have been treated for epilepsy (treatment-naïve) or have been
treated with no more than 1 standard antiepileptic drug (AED) if temporary or urgent
AED use was necessary. Previous AED exposure must not exceed either of the following:
1.)Thirty-one days immediately preceding enrollment, or 2.)A total of 6 months of
previous AED exposure in the past if the AED has been discontinued for at least 1 year
prior to enrollment

- Parents (or legally acceptable representatives) of the participant must sign an
informed consent/permission document, indicating that they understand the purpose of
and procedures required for the study and are willing to give permission for their
child to participate in the study. Participant 7 years of age and older, capable of
understanding the nature of the study, must provide assent for their participation

Exclusion Criteria:

- Participant has a surgically implanted and functioning vagus nerve stimulator

- Participant has a history of seizures as a result of a correctable medical condition,
such as metabolic disturbance, toxic exposure, neoplasm, or active infection within 2
weeks prior to the first day of Screening

- Participant has had uncontrolled seizures while previously taking either topiramate or
levetiracetam

- Participant has a history of non-epileptic seizures within 2 weeks prior to the first
day of Screening

- Participant has myoclonic or absence seizures