A Double-blind Confirmatory Trial of Levetiracetam in Epilepsy Patients With Partial Onset Seizures

Inclusion Criteria: Epileptic patients who fulfill the following criteria are eligible for inclusion in thestudy:

• Subjects aged from 16 to 65 years at the acquisition of informed consent to the trialparticipation

• Seizure type: subjects with epileptic seizures which were diagnosed as partialseizures more than 2 years ago according to "Clinical and electroencephalographicclassification of epileptic seizures (1981)" defined by the International LeagueAgainst Epilepsy (ILAE) and confirmed with an EEG that has been performed within 1year before Screening or at the Screening Visit

• Subjects whose previous therapy before screening involved at least two standardanti-epileptic drugs (AEDs) for partial seizures, and in whom it can be confirmed thatthe doses met the daily dose specified for the treatment of epilepsy in the packageinsert and that the therapy has been continued for at least 3 months

• Frequency of epileptic seizures: subjects experiencing partial seizures at least 12times in 12 weeks during the Baseline Period (Week −12 to Week 0) and at least twicein every 4 weeks

Exclusion Criteria: The following patients are not eligible for inclusion into the study:

• Subjects who were diagnosed with status epilepticus within 3 months before screening

• Subjects with no partial seizures of which frequency was measured during the BaselinePeriod

• Subjects who underwent surgery for epilepsy within 2 years before Screening or whowere scheduled to undergo brain surgery during the study period and within 4 weeksafter the completion of this study

• Subjects with a history of oral treatment with Levetiracetam (LEV)