A Study of the Efficacy and Safety of Topiramate as add-on Therapy in the Treatment of Epilepsy Patients With Difficult to Treat, Partial-onset Seizures.
Condition: Epilepsy; Epilepsies, Partial; Seizures
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the efficacy and safety of topiramate in epilepsy
      patients with difficult to treat, partial-onset seizures who are taking one or two standard
      antiepileptic 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 to evaluate topiramate
      efficacy and safety as add-on therapy in partial epilepsy patients. This study includes a
      baseline phase and a treatment phase. During the baseline phase (8 weeks duration), patients
      receive one or two standard antiepileptic drugs (AEDs), such as phenytoin, carbamazepine,
      phenobarbital, primidone, or valproic acid. Patients who continue to have seizures during
      treatment with standard AEDs proceed into the double-blind treatment phase. Patients then
      receive topiramate or placebo at a dosage of 100 milligrams once daily, increasing gradually
      over 3 weeks to 2 tablets twice daily (400 mg/day) or maximum tolerated dose, and maintained
      on that dose for 8 weeks (11 weeks is the 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 patient's and
      investigator's global assessments of medication at end of study. Safety assessments include
      the incidence of adverse events throughout the study, clinical laboratory tests (hematology,
      serum chemistry, urinalysis), neurologic examinations, and vital sign measurements (blood
      pressure, pulse, temperature) weekly 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 patients with refractory partial epilepsy: that is, in
      patients who continue to have seizures despite treatment with a first-line AEDs. In addition,
      it is hypothesized that topiramate is well tolerated. Topiramate, 100 milligrams (mg) oral
      tablets (or placebo). Dosage begins at 100 mg once daily and increases gradually over 3 weeks
      to 2 tablets twice daily (400 mg/day, maximum) or maximum tolerated dose for an additional 8
      weeks.
    

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; brain diseases