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Adjunctive lamotrigine for partial seizures in patients aged 1 to 24 months.

Author(s): Pina-Garza JE, Levisohn P, Gucuyener K, Mikati MA, Warnock CR, Conklin HS, Messenheimer J

Affiliation(s): From Vanderbilt University, Nashville, TN (J.E.P.-G.); The Children's Hospital of Denver, Denver, CO (P.L.); Gazi University, Ankara, Turkey (K.G.); American University Medical Center, Beirut, Lebanon (M.A.M.); and Neuroscience Medicine Development Center, GlaxoSmithKline, Research Triangle Park, NC (C.R.W., H.S.C., J.M.).

Publication date & source: 2007-12-12, Neurology., [Epub ahead of print]

OBJECTIVE: This randomized, double-blind, placebo-controlled trial was conducted to assess the efficacy and tolerability of adjunctive lamotrigine for the treatment of partial seizures in infants aged 1 to 24 months. METHODS: The study used a responder-enriched design in which all patients received adjunctive lamotrigine during an open-label phase (n = 177; maximum maintenance dose 5.1 mg/kg/day for those on non-enzyme-inducing antiepileptic drugs [AEDs] or valproate and 15.6 mg/kg/day for those on enzyme-inducing AEDs). Patients meeting response criteria were randomly assigned to double-blind treatment for up to 8 weeks with continued lamotrigine (n = 19) or to withdrawal from lamotrigine (placebo; n = 19) while background AEDs were maintained. RESULTS: The proportion of treatment failures (patients who met escape criteria or withdrew before completing the double-blind phase) was lower with lamotrigine (58%) than with placebo (84%). This finding was not significant in the primary analysis (two-sided chi(2) test [primary endpoint]). A post hoc sensitivity analysis of the primary endpoint was also performed (p = 0.045 by one-sided, mid-p corrected Fisher exact test). The median time to meet escape criteria was longer with lamotrigine (42 days) than with placebo (22 days) (p = 0.059). During the last 28 days of the open-label phase, 53% of the patients had a >/=50% reduction in frequency of partial seizures with lamotrigine. Additional reduction in partial seizure frequency was observed during the double-blind phase compared with the last 4 weeks of the open-label phase among those randomly assigned to lamotrigine (32% with a >/=25% reduction) but not those randomly assigned to placebo (5% with a >/=25% reduction). Lamotrigine was well tolerated, with an adverse event profile comparable to that observed in older pediatric patients. CONCLUSION: Lamotrigine was well tolerated, and the data indicate that it may be efficacious in the treatment of partial seizures in infants aged 1 to 24 months.

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