A Study for 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 3:

  • EEG at some time in past demonstrating focal abnormalities consistent with partial seizures
  • If the EEG is inconclusive or does not support partial seizures, then an MRI/CT will be done
  • If the MRI/CT fails to support a diagnosis of partial seizures, the subject may still qualify based on the principal Investigator's clinical diagnosis
• Subject weighs at least 15 kg (33 lbs).
• Parent/caregiver is able to keep an accurate seizure diary.

Exclusion Criteria:

• Has had status epilepticus in the past 3 months prior to Screening
• Has a history of any of: 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
• Receiving systemic chemotherapy
• Requires treatment with aspirin
• Subject is pregnant
• 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)