Childhood Absence Epilepsy Rx PK-PD-Pharmacogenetics Study

• Status: Completed
• Trial end date: 2016-08-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the best initial treatment for childhood absence epilepsy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)
• Treatments: Anticonvulsants; Ethosuximide; Lamotrigine; Valproic Acid

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.