One hundred twenty children aged 10 months to 16 years 9 months were i
ncluded in three studies with lamotrigine (LTG): a single-blind study
(n = 60), a pharmacokinetic study (n = 23), and a compassionate group
(n = 37). At 3 months, 11 patients had become seizure-free and 34 had
>50% decrease in seizure frequency. The best results involved absence
epilepsy, Lennox-Gastaut syndrome (LGS), and other symptomatic general
ized epilepsy. Forty-two patients were followed >1 year, 22 for a mean
of 2.2 years, and there was no significant increase in seizure freque
ncy as compared with 3-month follow-up. Fourteen patients became seizu
re-free for >6 months; all except 1 had generalized epilepsy. For 12 p
atients, treatment could be reduced to monotherapy, but for those with
valproate (VPA) comedication LTG dosage had to be increased; 25% of p
atients with VPA monotherapy exhibited skin rash, appearing 3-18 days
after starting LTG. For 4 patients, LTG could be reintroduced after VP
A was withdrawn. Ten patients had ataxia and/or drowsiness and 2 had v
omiting. For all other patients, tolerance was excellent.