A Study of the Effectiveness and Safety of Topiramate in the Treatment of Children With Epilepsy
Condition: Epilepsy; Epilepsies, Partial; Seizures
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of oral topiramate as
      add-on therapy in children with uncontrolled partial onset seizures who are taking one or two
      standard anti-epileptic drugs.
    

Detailed description: 
      Epilepsy is characterized by seizures, which are abnormal electrical discharges in the brain
      that temporarily disrupt normal brain function. Seizures are classified as "generalized,"
      originating in both sides of the brain simultaneously, or "partial-onset," starting in one
      area of the brain. Antiepilepsy medications, such as topiramate, are selected based on
      seizure type. This is a double-blind, placebo-controlled study that includes a baseline phase
      and a treatment phase. During the baseline phase (8 weeks duration), patients receive a
      stable dose of one or two standard antiepileptic drugs (AEDs), and the parent or guardian
      records the occurrences of seizure in a diary. Patients who continue to have seizures during
      treatment with standard AEDs proceed into the double-blind treatment phase. Patients then
      receive topiramate or placebo once daily at a dosage of 25 milligrams[mg] or 50 mg based on
      body weight (to 6mg/kg per day), increasing gradually to twice daily dosing at a maximum of
      125-400 mg (based on body weight) for 112 days (16 weeks total duration of the double-blind
      phase), while continuing on their standard AED regimen. Assessments of effectiveness include
      the percent reduction in the average monthly seizure rate, percent of patients responding to
      treatment (having equal to or greater than 50% reduction in seizure rate), and the parent's
      or guardian's global assessment of medication at end of study. Safety assessments include the
      incidence of adverse events throughout the study, clinical laboratory tests (hematology,
      chemistry, urinalysis), neurologic examinations, and vital sign measurements (blood pressure,
      pulse, body weight) at specific intervals during the treatment phase. The study hypothesis is
      that topiramate, taken as add-on therapy to treatment with AEDs, will significantly reduce
      seizure frequency, compared with placebo, in children with refractory partial epilepsy: that
      is, children who continue to have seizures despite treatment with first-line AEDs. In
      addition, it is hypothesized that topiramate is well-tolerated. Oral topiramate, daily for
      112 days. Starting dose is 25 mg or 50mg, based on body weight. Maximum doses based on
      patient weight: 125 mg/day (36-54 pounds[lb]); 175 mg/day (55-74 lb); 225 mg/day (75-94 lb);
      and 400 mg/day (95 or more pounds). Matching placebo was used to maintain blinding.
    

Intervention name(s): topiramate
Intervention type(s): Drug
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: topiramate; epilepsy; partial epilepsies; partial epilepsy; seizures; epileptic seizures; partial seizure disorder; children; pediatric