Childhood Absence Epilepsy Rx PK-PD-Pharmacogenetics Study
United States453 participantsStarted 2004-07
Plain-language summary
The purpose of this study is to determine the best initial treatment for childhood absence epilepsy.
Who can participate
Age range30 Months – 13 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Number of Participants With Freedom From Treatment Failure at 16-20 Weeks of Double Blind Therapy
Timeframe: First 16-20 weeks of double blind therapy
Trial details
NCT IDNCT00088452
SponsorChildren's Hospital Medical Center, Cincinnati