Gabapentin in naive childhood absence epilepsy: results from two double-blind, placebo-controlled, multicenter studies
| Autor: | Virginia Trudeau, Sharie L. Myers, Elizabeth Garofalo, Henning Anhut, John S. Ebersole, Linda LaMoreaux |
|---|---|
| Rok vydání: | 1996 |
| Předmět: |
Male
Gabapentin Cyclohexanecarboxylic Acids Acetates Placebo law.invention 03 medical and health sciences Epilepsy 0302 clinical medicine Childhood absence epilepsy Randomized controlled trial Double-Blind Method law 030225 pediatrics medicine Humans Amines Adverse effect Child gamma-Aminobutyric Acid Dose-Response Relationship Drug business.industry Electroencephalography medicine.disease Clinical trial Treatment Outcome Epilepsy Absence Anesthesia Child Preschool Pediatrics Perinatology and Child Health Anticonvulsants Female Neurology (clinical) medicine.symptom Drug Monitoring business 030217 neurology & neurosurgery Somnolence medicine.drug |
| Zdroj: | Journal of child neurology. 11(6) |
| ISSN: | 0883-0738 |
| Popis: | Efficacy and safety of gabapentin monotherapy were evaluated in 33 children with newly diagnosed absence epilepsy in two identical, double-blind, placebo-controlled trials in which a 2-week double-blind treatment phase was followed by a 6-week open-label phase. Primary efficacy criterion was seizure frequency change from baseline to end of double-blind treatment derived from quantified electroencephalograms. Primary efficacy analyses compared treatment differences in the 2-week double-blind phase. Gabapentin did not significantly decrease or increase seizure frequency compared with placebo. Low dosages with possibly subtherapeutic plasma levels may have contributed to the lack of demonstrable efficacy. Somnolence and dizziness were the only adverse events reported by at least two patients during gabapentin treatment. No clinically important changes in laboratory assessments or other safety parameters were observed. Gabapentin monotherapy at dosages ranging from 9.7 through 19.1 mg/kg/day is well tolerated in pediatric patients aged 4 through 12 years with absence epilepsy. (J Child Neurol 1996;11:470-475). |
| Databáze: | OpenAIRE |
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