a study to investigate the safety of the drugs topiramate and levetiracetam in treating children recently diagnosed with epilepsy

Conditions: Epilepsy

Summary: the purpose of this study is to evaluate the safety of topiramate monotherapy compared with levetiracetam another standard antiepileptic drug (aed), as monotherapy for new-onset or recent-onset epilepsy (seizure disorder) on pediatric growth and maturation, bone mineralization, and kidney stone formation in children aged 2 to 15 years.

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.

Eligibility criteria:
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

Keywords: epilepsy topiramate levetiracetam pediatric