A placebo-controlled trial of lamotrigine add-on therapy for partial seizures in children

Objective: To compare the safety and efficacy of add-on lamotrigine and pla cebo in the treatment of children and adolescents with partial seizures. Ba ckground: Add-on and monotherapy lamotrigine is safe and effective in adult s with partial seizures, and reports of preliminary uncontrolled trials sug gest similar benefits in children. Methods: We studied 201 children with di agnoses of partial seizures of any subtype currently receiving stable conve ntional regimens of antiepileptic therapy at 40 study sites in the United S tates and France. After a baseline observation period (to confirm that more than four seizures occurred in each of two consecutive 4-week periods), pa tients were randomized to add-on lamotrigine or placebo therapy. A 6-week d ose-escalation period was followed by a 12-week maintenance period. Results : Compared with placebo, lamotrigine significantly reduced the frequency of all partial seizures and the frequency of secondarily generalized partial seizures in these treatment-resistant patients. The most commonly reported adverse events in the lamotrigine treated patients were vomiting, somnolenc e, and infection; the frequency of these and other adverse events was simil ar to that in the placebo-treated group, with the exception of ataxia, dizz iness, tremor, and nausea, which were more frequent in the lamotrigine-trea ted group. The frequency of withdrawals for adverse events was similar betw een groups. Two patients were hospitalized for skin rash, which resolved af ter discontinuation of lamotrigine therapy, Conclusions: Lamotrigine was ef fective for the adjunctive treatment of partial seizures in children and de monstrated an acceptable safety profile.