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 five open add-on studies have been analyzed. All the children had treatment-resistant epilepsy and most had two or more seizure types. Seizure frequency and global evaluation were assessed at the end of four successive 12-week periods of therapy. RESULTS: Seizure frequency was reduced by 50% or more in one third of the patients. Lamotrigine was effective in all seizure types examined, particularly for typical and atypical absence seizures. Atonic seizures also responded well. Improvement was well maintained during the treatment period. The maintenance dose 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 mg/kg per day for those not taking valproate. The commonest reported adverse experiences were somnolence, rash, vomiting, and seizure exacerbations. Adverse experiences led to withdrawal of treatment from 36 patients (12.6%). CONCLUSIONS: These results indicate that lamotrigine is well tolerated and is effective for a broad range of seizure types, especially absence seizures and atonic seizures.
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 five open add-on studies have been analyzed. All the children had treatment-resistant epilepsy and most had two or more seizure types. Seizure frequency and global evaluation were assessed at the end of four successive 12-week periods of therapy. RESULTS:Seizure frequency was reduced by 50% or more in one third of the patients. Lamotrigine was effective in all seizure types examined, particularly for typical and atypical absence seizures. Atonic seizures also responded well. Improvement was well maintained during the treatment period. The maintenance dose 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 mg/kg per day for those not taking valproate. The commonest reported adverse experiences were somnolence, rash, vomiting, and seizure exacerbations. Adverse experiences led to withdrawal of treatment from 36 patients (12.6%). CONCLUSIONS: These results indicate that lamotrigine is well tolerated and is effective for a broad range of seizure types, especially absence seizures and atonic seizures.