GABAPENTIN IN NAIVE CHILDHOOD ABSENCE EPILEPSY - RESULTS FROM TO DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDIES

Efficacy and safety of gabapentin monotherapy were evaluated in 33 chi ldren with newly diagnosed absence epilepsy in two identical, double-b lind, placebo-controlled trials in which a 2-week double-blind treatme nt phase was followed by a 6-week open-label phase. Primary efficacy c riterion was seizure frequency change from baseline to end of double-b lind 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 sei zure frequency compared with placebo. Low dosages with possibly subthe rapeutic plasma levels may have contributed to the lack of demonstrabl e efficacy. Somnolence and dizziness were the only adverse events repo rted by at least two patients during gabapentin treatment. No clinical ly important changes in laboratory assessments or other safety paramet ers 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.