Childhood Absence Epilepsy Rx PK-PD-Pharmacogenetics Study

Completed · Phase 3

Conditions studied: Childhood Absence Epilepsy, Petit Mal Epilepsy, Epilepsy, Seizures

In brief

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

Key facts

Study ID

NCT00088452

Run by

Children's Hospital Medical Center, Cincinnati

People needed

453

Starts

2004-07-01

Expected to finish

2016-08-31

Last updated by the study team

2020-10-14

Who can join

Age: 3 and older, up to 13. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• The Children's Hospital of Alabama — Birmingham, Alabama, United States
• St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• University of California at San Diego — La Jolla, California, United States
• Mattel Children's Hospital at UCLA — Los Angeles, California, United States
• Children's Hospital of Denver — Denver, Colorado, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Nemours Children's Clinic — Jacksonville, Florida, United States
• Miami Children's Hospital — Miami, Florida, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Children's Memorial Hospital — Chicago, Illinois, United States
• Children's Hospital of Michigan — Detroit, Michigan, United States
• Washington University in St. Louis — St Louis, Missouri, United States
• Women and Children's Hospital of Buffalo — Buffalo, New York, United States
• NYU Comprehensive Epilepsy Center, Manhattan — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Cincinnati Children's Hospital — Cincinnati, Ohio, United States
• Rainbow Babies & Children's Hospital — Cleveland, Ohio, United States
• Children's Hospital, Inc., PCTI — Columbus, Ohio, United States
• Doernbecher Children's Hospital — Portland, Oregon, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• LeBonheur Children's Medical Center — Memphis, Tennessee, United States
• Dallas Pediatric Neurology Associates — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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