A Study of the Safety and Efficacy of Depakote Sprinkle Capsules in the Treatment of Partial Seizures in Children

Exclusion Criteria

• •History of any of following: Lennox-Gastaut syndrome; Primary generalized seizures; Infantile spasms; Mixed seizure disorders including atypical absence; Myoclonic or atonic seizures; Pseudoseizures or Epilepsia Partialis Continuans (EPC)
• •Has had status epilepticus in the past 6 months
• •Has significant history of any of following that would confound study results: Cardiac (including clinically important abnormality on ECG); Renal; Psychiatric (including psychosurgery); Oncologic; Endocrine; Metabolic; Pancreatic; Hepatic disease (including clinical/serological history of hepatitis); Urea cycle disorder
• •Has: Expanding CNS neoplasm; Active CNS infection; Demyelinating disease; Degenerative neurological disease; Progressive encephalopathy; or any Progressive CNS disease
• •Has platelet count less than or equal to 100,000/mcL
• •Has blood chemistry ALT/AST value(s) greater than or equal to 2 times upper limit of normal at screening
• •Requires anticoagulant drug therapy
• •Not expected to be able to maintain same dose of all pre-study AEDs, excluding valproate, throughout study
• •Receiving systemic chemotherapy
• •Has taken lamotrigine, felbamate, or pemoline, within past 3 months prior to screening
• •Has been on ketogenic diet within 30 days prior to screening
• •Considered by investigator to be non-responder to valproate for treatment of epilepsy (e.g., Despite adequate trial with serum concentrations of 60 mcg/mL or greater, subject continues to have inadequate seizure control)