Sixty-nine children, aged from 2 months to 16 years and suffering from
different types of drug-resistant epileptic seizures, mostly complex
partial and secondary generalised, were recruited in an open, uncontro
lled, prospective study of treatment with vigabatrin (gamma-vinyl GABA
). Following a 3-month baseline observation period, the initial dose o
f vigabatrin of 10 mg/kg per day was progressively increased up to a m
aximum of 140 mg/kg per day, in addition to the conventional concomita
nt therapy. Sixteen patients showed a greater-than-or-equal-to 50% red
uction in seizure frequency compared with the baseline, with complete
control of seizures in nine cases. In 14 other patients, no substantia
l change in seizure frequency was observed, although an improvement in
psychological performance after vigabatrin treatment warranted furthe
r continuation of the drug. In 35 patients vigabatrin was discontinued
because of lack of efficacy (22 cases) and/or increased seizure frequ
ency (13 cases). The clinical and biological tolerance of vigabatrin w
as remarkably good.