For generalized seizures associated with the Lennox-Gastaut syndrome

Background The Lennox-Gastaut syndrome, a severe form of epilepsy that usually begins in early childhood, is difficult to treat. Dose-related drug toxicity is common. Methods We conducted a double-blind, placebo-controlled trial of the antiepileptic drug lamotrigine in patients with the Lennox-Gastaut syndrome. Eligible patients had more than one type of predominantly generalized seizure, including tonic-clonic, atonic, tonic, and major myoclonic, and had seizures on average at least every other day. After a 4-week base-fine period in which all participants received placebo, we randomly assigned 169 patients (age range, 3 to 25 years) to 16 weeks of lamotrigine (n=79) or placebo (n=90) in addition to their other antiepileptic drugs. Results The median frequency of ail major seizures changed from base-line levels of 16.4 and 13.5 per week in the lamotrigine and placebo groups, respectively, to 9.9 and 14.2 per week after 16 weeks of treatment (P=0.002). Thirty-three percent of the patients in the lamotrigine group and 16 percent of those in the placebo group had a reduction of at least 50 percent in the frequency of seizures (P=0.01). There were no significant differences between groups in the incidence of adverse events, except for colds or viral illnesses, which were more common in the lamotrigine group (P=0.05). Conclusions Lamotrigine was an effective and well-tolerated treatment for seizures associated with the Lennox-Gastaut syndrome. (C) 1997, Massachusetts Medical Society.