A double blind, randomised, placebo-controlled, mulitcentre study to assess the efficacy and safety of adjunctive zonisamide in primary generalised tonic clonic seizures.

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This study is designed to compare how safe and effective zonisamide is compared to placebo in people with primary generalised tonic clonic seizures who are already being treated with one or two other anti-epileptic drugs. Zonisamide is an investigational drug. Primary Research Objective: To assess the efficacy of adjunctive zonisamide in IGE in reducing the frequency of tonic-clonic seizures in subjects with continuing continuing primary generalised tonic-clonic seizures Secondary Research Objective: To assess the safety and tolerability of adjunctive zonisamide. Exploratory Research Objective: To further explore the efficacy of zonisamide on other seizure types expected to occur in a significant proportion of subjects (myoclonic seizures, absence seizures). This is a double-blind, randomised, placebo-controlled study comparing zonisamide and placebo in 154 subjects (1:1 ratio). The study consists of Baseline, Titration and Maintenance periods. Baseline Period - once the Screening Visit has been performed, a seizure diary will be maintained to document the baseline seizure frequency in the eight weeks before the Randomisation Visit. Titration Period - zonisamide/placebo dose will commence at 1 mg/kg in subjects <12 years of age or at 50 mg for subjects 12 years of age. Further dose increases will occur at one week intervals until at dose of 5 mg/kg or 300 mg is reached by Week 4. If adverse events (AEs) occur, one titration step will be omitted during Weeks 0-3, in which case the dose reached at Week 4 will be 4 mg/kg or 250 mg. Subject's who require further down titration will be withdrawn from the study. Maintenance Period - subjects will be treated with their Week 4 dose. In the event of seizures occurring in the first two weeks of the Maintenance Period, the dose will be increased to 6 mg/kg or 400 mg (or 5 mg/kg or 350 mg, if the subject omitted one dose in the Titration Period and the AE that led to this dose increase omission has subsided). The dose will be reduced to 4 mg/kg or 200 mg in dose-limiting AEs. Subjects who require further down titration or dose increases will be withdrawn (with the exception of those who had temporary dose decreases for not more that 4 days when necessitated by intercurrent illness). During the remainder of the Maintenance Period, the dose of study medication must remain unchanged. During the entire study the patient will keep a seizure diary to ascertain seizure frequency and type. Adverse events (AEs) will be reviewed at every visit, also physical and neurological exams, orthostatic vitals, 12 lead ECGs and clinical labs will be collected at every visit.

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