Gabapentin in naive childhood absence epilepsy: results from two double-blind, placebo-controlled, multicenter studies.
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.
Trudeau
V
V
Parke-Davis Pharmaceutical Research, Division of Warner-Lambert Company, Morris Plains, NJ, USA.
Myers
S
S
LaMoreaux
L
L
Anhut
H
H
Garofalo
E
E
Ebersole
J
J
D000085:Acetates / Q000009:adverse effects / Q000627:therapeutic use*; D000588:Amines; D000927:Anticonvulsants / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D003509:Cyclohexanecarboxylic Acids; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D016903:Drug Monitoring; D004569:Electroencephalography / Q000187:drug effects; D004832:Epilepsy, Absence / Q000175:diagnosis / Q000188:drug therapy*; D005260:Female; D000077206:Gabapentin; D006801:Humans; D008297:Male; D016896:Treatment Outcome; D005680:gamma-Aminobutyric Acid
D000085:Acetates; D000588:Amines; D000927:Anticonvulsants; D003509:Cyclohexanecarboxylic Acids; D005680:gamma-Aminobutyric Acid; D000077206:Gabapentin