Fourteen children (6 M, 8 F) suffering from refractory epilepsy receiv
ed LTG as add-on therapy. LTG was administered twice daily at dosages
increasing up to 2 mg/kg/day (for patients taking VPA) or to 10 mg/kg/
day for patients taking AEDs that induce hepatic metabolism. The drug
was withdrawn for side effects in 3 cases (rash: two cases, hirsutism:
one), because of increased seizure frequency in 2 cases and because o
f unchanged seizure frequency in one. One patient died from acute resp
iratory failure, after repeated respiratory tract infections. A decrea
se in seizure frequency after one year of treatment with LTG was obser
ved in 6 of the 7 patients who completed the study. The median total s
eizure frequency decreased from 10.7 +/- 7.3 to 3.8 +/- 4.6 seizures p
er day. At the end of the study, seizure frequency had decreased by mo
re than 50 % in 2 patients, by more than 75 % in 2 patients, and 2 pat
ients were seizure-free; in the remaining patient seizure frequency wa
s unchanged. The best results were obtained with plasma LTG concentrat
ions ranging from 0.5 to 5.4 mug/ml; no further improvement was observ
ed at higher LTG concentrations.