THE EFFICACY OF LAMOTRIGINE IN CHILDREN AND ADOLESCENTS WITH REFRACTORY GENERALIZED EPILEPSY - A RANDOMIZED, DOUBLE-BLIND, CROSSOVER STUDY

Purpose: We report a double-blind, placebo-controlled crossover study of lamotrigine (LTG) as add-on treatment in therapy-resistant, general ized epilepsy in children and adolescents (n = 30). Methods. Twenty pa tients had Lennox-Gastaut syndrome. Each patient acted as his or her o wn control. LTG and placebo were randomly added to existing antiepilep tic medication (AEDs). The LTG dosage was individualized in an open ph ase preceding the placebo/treatment phase. Patients who responded to L TG in the open phase went on to the double-blind phase. ''Responders'' were defined as patients with a >50% seizure reduction or less severe seizures or both, or improved behavior or improved motor skills or bo th. ''Nonresponders'' were defined as children who showed no positive effects of LTG with plasma levels of less than or equal to 10 mu g/ml or children who had adverse events during the open phase. Results: The re was a clear statistically significant reduction of seizure frequenc y in LTG compared with placebo treatment. None of the children studied showed abnormal biochemical or hematologic findings, or changes in pl asma levels of concomitantly administered AEDs. Conclusions: LTG is a well-tolerated and effective treatment in children with intractable ge neralized epilepsies, including those with Lennox-Gastaut syndrome. Th e study design allowed a double-blind placebo-controlled assessment of LTG although the participating children used 19 different AED combina tions at entry.