Study to Evaluate the Safety and Efficacy of Levetiracetam in Patients Suffering From Idiopathic Generalized Epilepsy With Primary Generalized Tonic-clonic Seizures
Study to Evaluate the Safety and Efficacy of Levetiracetam in Patients Suffering From Idiopathic Generalized Epilepsy With Primary Generalized Tonic-clonic Seizures
This study will assess the efficacy, safety, and tolerability of adjunctive treatment with
 LEV (3,000 mg/day or a target dose of 60 mg/kg/day in children) compared to placebo in
 reducing PGTC seizures in subjects (4 - 65 years) suffering from idiopathic generalized
 epilepsy uncontrolled despite treatment with one or two concomitant AEDs.
Inclusion Criteria:

 -  Subject with a confirmed diagnosis consistent with idiopathic generalized epilepsy
 experiencing primary generalized tonic-clonic seizures (IIE) that are classifiable
 according to the ILAE Classification of Epileptic Seizures.

 -  Presence of at least 3 PGTC seizures during the 8-week combined Baseline period.

 -  Absence of brain lesion documented on a CT scan or MRI.

 -  An EEG performed within 1 year of Visit 1 with features consistent with PGTC seizures
 or generalized idiopathic epilepsy.

 -  Male/female subject, >=4 or <=65 years of age at Visit 1.

 -  Subject on a stable dose of one or two AEDs during baseline.

 Exclusion Criteria:

 -  Previous exposure to levetiracetam.

 -  History of partial seizures.

 -  History of convulsive or non-convulsive status epilepticus while taking concomitant
 AEDs within three months prior to Visit 1.