A Study of Levetiracetam as Monotherapy or Adjunctive Treatment of Partial Seizures in Pediatric Epileptic Subjects Ranging From 1 Month to Less Than 4 Years of Age

Exclusion Criteria

• •Subject has been taking any medication (other than their concomitant AEDs) that influences the central nervous system (CNS) for which they had not been on a stable regimen for at least 1 month prior to Visit 1
• •Subject is taking any medication that may interfere with the absorption, distribution, metabolism, or excretion of the concomitant AEDs or levetiracetam (LEV) during the course of the study
• •Subject has received any investigational medication or device within 30 days prior to Visit 1
• •Subject has taken LEV prior to the study
• •Subjects using felbamate who have presented with clinically significant abnormalities and/or hepatic function during felbamate treatment, and subjects who are taking felbamate \<1year from the date of Visit 1
• •History of status epilepticus requiring hospitalization during the 30 days prior to Visit 1, except for status epilepticus occurring during the first 10 days of life
• •Subject has a treatable seizure etiology
• •Subject is on a ketogenic diet (concomitantly or within 30 days prior to Visit 1)
• •Subject has epilepsy secondary to progressing cerebral diseases
• •Subject has a current diagnosis of Rasmussen's syndrome, Landau-Kleffner disease or Lennox-Gastaut syndrome
• •Clinically significant deviations from reference range values for renal function or any of the other laboratory parameters required for this study, as determined by the Investigator
• •Clinically significant acute or chronic illness (as determined during the physical examination or from other information available to the Investigator)
• •Allergy to pyrrolidine derivatives or a history of multiple drug allergies
• •Subject is known to have a terminal illness
• •Subject has a disorder or condition that may interfere with the absorption, distribution, metabolism, or excretion of medications
• •Subject has a history of or presence of pseudoseizures
• •Subject has any medical condition that might interfere with the subject's study participation
• •Subject has ≥3x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or \>ULN total bilirubin (≥1.5xULN total bilirubin if known Gilbert's syndrome). If subject has elevations only in total bilirubin that are \>ULN and \<1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert's syndrome (ie, direct bilirubin \<35%)