The purpose of this study is to compare the safety and efficacy of two concentration ranges of valproate using Depakote Sprinkle Capsules as adjunctive therapy in the treatment of partial seizures, with or without secondary generalization, in children 3-10 years.

Condition	Treatment or Intervention	Phase
Partial Seizure Disorder	Drug: Divalproex Sodium (Depakote® Sprinkle Capsules)	Phase III

Ages Eligible for Study:  3 Years   -   10 Years,  Genders Eligible for Study:  Both

Criteria

KEY 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

KEY 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)

Florida
      Pediatric Epilepsy & Neurology Specialist, Tampa,  Florida,  33607,  United States
Ohio
      PCTI / Children's Hospital, Columbus,  Ohio,  43205,  United States
      University Hospital of Cleveland, Cleveland,  Ohio,  United States
      Rainbow Babies Children's Hospital, Cleveland,  Ohio,  44106,  United States
Pennsylvania
      Primary Physician's Research, Pittsburgh,  Pennsylvania,  United States
Texas
      Texas Association of Pediatric Neurology, PA, San Antonio,  Texas,  78258,  United States
Virginia
      Virginia Commonwealth University, Richmond,  Virginia,  23298-0211,  United States

Study ID Numbers:  M02-552
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  August 19, 2003
ClinicalTrials.gov Identifier:  NCT00067431
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08