A Study of the Efficacy and Safety of Topiramate as an add-on Therapy in the Treatment of Epilepsy Patients With Lennox-Gastaut Syndrome
Condition: Epilepsy; Seizures
MeSH terms: Epilepsy; Seizures; Lennox Gastaut Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effectiveness and safety of topiramate as add-on
      therapy in the treatment of epilepsy patients with Lennox-Gastaut syndrome, a severe form of
      epilepsy in which there are mixed types of seizures.
    

Detailed description: 
      Lennox-Gastaut syndrome is a severe form of epilepsy that usually develops in children 4
      years of age and younger. It is characterized by several seizure types and developmental
      delay. Tonic seizures, in which the muscle tone is greatly increased and body, arms and legs
      make sudden stiffening movements, is particularly common in Lennox-Gastaut syndrome. Although
      atonic seizures, in which there is a sudden loss of muscle tone and strength, can occur in
      individuals with this syndrome. Control of seizures is difficult because they are usually
      resistant to antiepileptic drugs. Topiramate is a drug that is currently widely used for the
      treatment of seizures in adults and pediatric patients (2 to 16 years of age). This is a
      randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy
      and safety of topiramate as an add-on therapy in patients with Lennox-Gastaut syndrome. The
      study is composed of two phases: baseline (28 days) and double-blind treatment (approximately
      11 weeks). Patients or their guardians/parents are given diaries to record information on
      seizures occurring during the study. During the baseline phase, the patient continues to
      receive the antiepileptic drug they have been taking. The double-blind phase is divided into
      two periods: titration, in which the topiramate dose was gradually increased (21 days)
      (patient's antiepileptic drug continues; this dose remains the same) and maintenance (56
      days). The dose of both topiramate and the patient's antiepileptic drug remain constant
      during the maintenance period. Based on the investigator's judgment, all patients completing
      the double-blind period could be enrolled into an extension phase of the study. The primary
      assessment of effectiveness is the percent reduction from baseline in seizure rates (all
      types of seizures) in the double-blind phase. Safety assessments include the frequency of
      adverse events, results of clinical laboratory tests (hematology, biochemistry, and
      urinalysis), measurements of vital signs and body weight, physical examination and
      electrocardiogram findings, and neurological examinations. The study hypothesis is that
      topiramate is superior to placebo in reducing the seizure rate from baseline in the double
      blind phase of the study and is well tolerated. Topiramate (25milligram [mg] or 100mg
      tablets) or placebo, taken by mouth, starting at a dose of 1mg/kilogram(kg)/day, gradually
      increasing over 3 weeks to a total dose of 6mg/kg/day (given twice daily in equal oral doses
      for 8 weeks). Maximum daily dose is <=600mg/day.
    

Intervention name(s): topiramate
Intervention type(s): Drug
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Epilepsy; Seizures; Topiramate; Prophylaxis; Antiepileptic; Lennox-Gastaut syndrome; Seizures, tonic