Childhood Absence Epilepsy Rx PK-PD-Pharmacogenetics Study
Condition: Childhood Absence Epilepsy; Petit Mal Epilepsy; Epilepsy; Seizures
MeSH terms: Epilepsy; Seizures; Epilepsy, Absence
Intervention: Ethosuximide; Lamotrigine; Valproic acid
Intervention description: Ethosuximide is a common treatment for childhood absence epilepsy.; Lamotrigine is a common treatment for childhood absence epilepsy.; Valproic acid is a common treatment for childhood absence epilepsy.
Intervention MeSH terms: Lamotrigine; Valproic Acid; Ethosuximide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 453.0
Sex: All
Minimum age: 30 Months
Maximum age: 13 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: childhood absence epilepsy; CAE; petit mal epilepsy; epilepsy; seizures; ethosuximide; lamotrigine; valproic acid

Summary:

      The purpose of this study is to determine the best initial 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.