Efficacy and Safety of Adjunctive Rufinamide in Lennox-Gastaut Syndrome (LGS): Results from Studies 022, 022E, 303, 304, and 305 (P1.273)

Objective: Present an overview of efficacy and safety for adjunctive rufinamide in LGS patients aged 1–30 years. Background: LGS, a rare epilepsy syndrome, affects 1–4% of children with epilepsy. Limited treatment options demonstrate inadequate seizure control and unfavorable tolerability. Design/Methods: Studies 022 (Glauser et al. Neurology 2008;70:1950–1958) and 304 (Ohtsuka et al. Epilepsy Res 2014;108:1627–1636) were Phase III, double-blind, placebo-controlled studies of adjunctive rufinamide in LGS patients aged 4–30 years (28-day Baseline; 84-day Treatment Phase). Rufinamide maintenance dose: 022, ≤45 mg/kg/day; 304, 800–3200 mg/day by body weight (15.0 to ≥70.1 kg). Patients completing 022 or 304 could enter an open-label extension (022E [Kluger et al. Acta Neurol Scand 2010;122:202–208]; 305 [Ohtsuka et al. Epilepsy Res 2016;121:1–7], respectively). The Phase III, randomized, open-label Study 303 (Arzimanoglou et al. EJPN 2016;20:393–402) assessed adjunctive rufinamide (45 mg/kg/day) versus any-other-AED (antiepileptic drug) in patients aged 1– Results: Median percent reduction in tonic-atonic seizure frequency: 022, 42.5% rufinamide (n=74) and −1.4% placebo (n=64; P P =0.003). Median percent reduction in total seizure frequency: 022, 32.7% rufinamide and 11.7% placebo ( P =0.0015); 304, 32.9% and 3.1%, respectively ( P Conclusions: There were significant reductions in seizure frequencies for adjunctive rufinamide versus placebo in LGS patients aged 4–30 years. Safety of adjunctive rufinamide was confirmed in LGS patients aged 1– Study Supported by: Eisai Inc. Disclosure: Dr. Arzimanoglou has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eisai, UCB, GW, Zogenix, Takeda, Shire, Upsher-Smith. Dr. Arzimanoglou has received research support from Eisai, Caixa Bank Spain, UCB. Dr. Kluger has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Gerhard Kluger has served on advisory boards and received speaking honoraria from UCB Inc. and Eisai Inc. Dr. Kluger has received research support from Eisai Inc. Dr. Muller has nothing to disclose. Dr. Ohtsuka has nothing to disclose. Dr. Williams has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Eisai Inc. Dr. Williams holds stock and/or stock options in Spouse is employee of Stryker Orthopedics. Dr. Williams has received research support from Employee of Eisai Inc. Dr. Bibbiani has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eisai employee. Dr. Perdomo has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Eisai Inc. Dr. Malhotra has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Eisai Inc.