Status:
COMPLETED
Childhood Absence Epilepsy Rx PK-PD-Pharmacogenetics Study
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Childhood Absence Epilepsy
Petit Mal Epilepsy
Eligibility:
All Genders
30-13 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the best initial treatment for childhood absence epilepsy.
Detailed Description
Childhood absence epilepsy (CAE) is a common pediatric epilepsy syndrome that affects 10 to 15 percent of all children with epilepsy. Individuals with CAE have brief staring spell seizures that occur ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2016
Estimated Enrollment :
453 Patients enrolled
Trial Details
Trial ID
NCT00088452
Start Date
July 1 2004
End Date
August 31 2016
Last Update
October 14 2020
Active Locations (31)
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1
The Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
2
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
3
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
4
University of California at San Diego
La Jolla, California, United States, 92093