Objective: In this multicenter study, the efficacy and tolerability of
lamotrigine were assessed in 285 children less than 13 years of age,
recruited from 37 centers in 11 countries. Methods: Pooled data from f
ive open add-on studies have been analyzed. All the children had treat
ment- resistant epilepsy and most had two or more seizure types. Seizu
re frequency and global evaluation were assessed at the end of four su
ccessive 12-week periods of therapy. Results: Seizure frequency was re
duced by 50% or more in one third of the patients. Lamotrigine was eff
ective in all seizure types examined, particularly for typical and aty
pical absence seizures. Atonic seizures also responded well. Improveme
nt was well maintained during the treatment period. The maintenance do
se had to be adjusted according to concomitant medication; dose ranges
were 1 to 5 mg/kg per day for children taking valproate and 5 to 15 m
g/kg per day for those not taking valproate, The commonest reported ad
verse experiences were somnolence, rash, vomiting, and seizure exacerb
ations. Adverse experiences led to withdrawal of treatment from 36 pat
ients (12.6%). Conclusions: These results indicate that lamotrigine is
well tolerated and is effective for a broad range of seizure types, e
specially absence seizures and atonic seizures.