A Study to Investigate the Safety of the Drugs Topiramate and Levetiracetam in Treating Children Recently Diagnosed With Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Topiramate; Levetiracetam
Intervention description: Topiramate weight based dosing for participants 2 to <10 years of age not to exceed 350 mg/day, as tolerated; not to exceed 400 mg/day in participants 10-15 years of age, as tolerated.; Levetiracetam weight based dosing for all participants 2-15 years of age, not to exceed 60 mg/kg/day, as tolerated. The maximum recommended daily dosage is 3,000 mg.
Intervention MeSH terms: Topiramate; Levetiracetam
Phase: Phase 3
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 2 Years
Maximum age: 15 Years
Healthy volunteers: No
Keywords: Epilepsy; Topiramate; Levetiracetam; Pediatric

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.
    

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