Intervention: VALPROIC ACID
Trial phase: Phase 3
ATC code: N03AG01
SMILES: CCCC(CCC)C(=O)O
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 147
Group description: Valproic acid

Frequency and Duration: twice a day, every day for the duration of the study treatment

Formulation: Two formulations were used (actual formulation used was dependent on the patient's weight): 250mg Depakote capsules OR 125mg Depakote sprinkles.

Dosing: Depakote was titrated in predetermined increments every 1-2 weeks during a 16-week titration period. The titration continued until the patient a) achieved seizure freedom by clinical and EEG criteria, b) reached the maximal allowed study drug dose, c) reached the maximal tolerated dose, or d) developed dose-exiting criteria (treatment failure), whichever came first. Maximum allowed dose: 60 mg/kg/day or 3000 mg/day (whichever was lower)

Valproic acid: Valproic acid is a common treatment for childhood absence epilepsy.
Eligibility criteria:
Inclusion Criteria:

Diagnosis: Clinical diagnosis of Childhood Absence Epilepsy consistent with the International League against Epilepsy Proposal for Revised Classification of Epilepsies and Epileptic Syndromes (3).
EEG: Interictal EEG demonstrating bilateral synchronous symmetrical approximate 3 Hz spike waves on a normal background with at least one burst lasting >/= (greater than or equal to) 3 seconds.
Age > 2.5 years and < 13 years of age at study entry.
Body weight >/= (greater than or equal to) 10 kilograms.
Body Mass Index: BMI for age =/< 99th percentile (based on the CDC BMI for age growth curves for boys/girls [http://www.cdc.gov/growthcharts], Appendix 1).
Hepatic:
AST/ALT < 2.5 times the upper limit of normal
Total bilirubin < 1.5 times the upper limit of normal.
Hematologic:
Absolute neutrophil count >/= (greater than or equal to) 1500/mm3.
Platelets >/= (greater than or equal to) 120, 000 /mm3.
Female subjects must be premenarchal at the time of enrollment and must be willing to practice abstinence for the duration of the study.
Parent/legal guardian(s) willing to sign an IRB approved informed consent.
Subject assent (when appropriate and as dictated by local IRB).

Exclusion Criteria:

Treatment for CAE with anti-seizure medications (AED) for a period of greater than 7 days prior to randomization.
History of a major psychiatric disease (e.g., psychosis, major depression).
History of autism or pervasive development disorder.
History of non-febrile seizures other than typical absence seizures. This includes a history of an afebrile generalized tonic clonic seizure.
Clinical signs and symptoms consistent with a diagnosis of juvenile absence epilepsy or juvenile myoclonic epilepsy as delineated by the International League against Epilepsy Proposal for Revised Classification of Epilepsies and Epileptic Syndromes (3).
History of recent or present significant or medical disease, i.e., cardiovascular, hepatic, renal, gynecologic, musculoskeletal, metabolic, or endocrine.
History of a severe dermatologic reaction (e.g., Stevens Johnson, toxic epidermolysis necrosis) to medication.
Subject or parent/legal guardian might not be reasonably expected to be compliant with or to complete the study.
Participation in a trial of an investigational drug or device within 30 days prior to screening.
Use of systemic contraceptive for any indication, including acne.