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

INCLUSION CRITERIA:

Subject has diagnosis of partial seizures with/without secondary generalization, supported by:

• Observed ictal events consistent with partial seizures: With/ without secondary generalization; Documented by reliable observers
• 1 of following 2: EEG at some time in past demonstrating focal abnormalities consistent with partial seizures; OR, in absence of demonstrable EEG abnormality: MRI/CT scan evidence of a focal CNS lesion consistent with partial seizures
• On stable dose of 1 or 2 antiepileptic drug(s) (AED) other than valproate, for at least 1 month
• Not taking valproate or is currently receiving valproate resulting in a trough concentration of less than 40 mcg/mL
• History of at least 4 partial seizures/month in 2 months prior to screening
• Parent/caregiver is able to keep an accurate seizure diary

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)