Adjunctive levetiracetam in infants and young children with refractory partial-onset seizures
Jesus Eric Piña-Garza, Douglas R Nordli Jr, Dietz Rating, Haichen Yang, Jimmy Schiemann-Delgado, Benjamin Duncan, Levetiracetam N01009 Study Group, L Lagae, P Van Bogaert, S A Antoniuk, J Costa da Costa, A Cukiert, M L G de Manreza, M H Ferreira-Mendes, M M Guerreiro, A C Sakamoto, J Hadac, V Komarek, H Oslejskova, C Chiron, A De Saint Martin, D Parain, L Vallée, U Brandl, J P Ernst, H-J Meencke, D Rating, U Stephani, R Trollmann, A Fogarasi, K Kollár, R Gaggero, R Guerrini, A Romeo, F Vigevano, S Garza-Morales, M Ruiz-Garcia, M Mazurkiewicz-Beldizinska, I Benga, V Foisoreanu, S Magureanu, S Aivazian, N Berezina, A Broutian, I Dykhanova, N Koroleva, M Lobov, H Cross, R Ayala, D Bettis, L W Brown, C Crosley, M Duchowny, V Faircloth, J Ferreira, M Frost, M Goyal, R S Greenwood, A Hernandez, A Kalra, M Kohrman, P Kotagal, E Liu, P Maertens, M Mintz, W G Mitchell, G Montouris, R P Morse, L Morton, Y Park, E Piña-Garza, C Roberts, M Sam, C Tardo, C B Van Orman, D Wang, A Weinstock, M L Zupanc, Jesus Eric Piña-Garza, Douglas R Nordli Jr, Dietz Rating, Haichen Yang, Jimmy Schiemann-Delgado, Benjamin Duncan, Levetiracetam N01009 Study Group, L Lagae, P Van Bogaert, S A Antoniuk, J Costa da Costa, A Cukiert, M L G de Manreza, M H Ferreira-Mendes, M M Guerreiro, A C Sakamoto, J Hadac, V Komarek, H Oslejskova, C Chiron, A De Saint Martin, D Parain, L Vallée, U Brandl, J P Ernst, H-J Meencke, D Rating, U Stephani, R Trollmann, A Fogarasi, K Kollár, R Gaggero, R Guerrini, A Romeo, F Vigevano, S Garza-Morales, M Ruiz-Garcia, M Mazurkiewicz-Beldizinska, I Benga, V Foisoreanu, S Magureanu, S Aivazian, N Berezina, A Broutian, I Dykhanova, N Koroleva, M Lobov, H Cross, R Ayala, D Bettis, L W Brown, C Crosley, M Duchowny, V Faircloth, J Ferreira, M Frost, M Goyal, R S Greenwood, A Hernandez, A Kalra, M Kohrman, P Kotagal, E Liu, P Maertens, M Mintz, W G Mitchell, G Montouris, R P Morse, L Morton, Y Park, E Piña-Garza, C Roberts, M Sam, C Tardo, C B Van Orman, D Wang, A Weinstock, M L Zupanc
Abstract
Purpose: To evaluate the efficacy and tolerability of adjunctive levetiracetam in very young children (aged 1 month to <4 years) with partial-onset seizures inadequately controlled with one or two antiepileptic drugs.
Methods: This multicenter, double-blind, randomized, placebo-controlled study consisted of a 48-h inpatient baseline video-EEG (electroencephalography) and a 5-day inpatient treatment period (1-day up-titration; 48-h evaluation video-EEG in the last 2 days). Children who experienced at least two partial-onset seizures during the 48-h baseline video-EEG were randomized to either levetiracetam [40 mg/kg/day (age 1 to <6 months); 50 mg/kg/day (age >or=6 months to <4 years] or placebo.
Results: Of 175 patients screened, 116 patients were randomized [60 levetiracetam; 56 placebo; intent-to-treat (ITT) population], and 111 completed the study. The responder rate in average daily partial-onset seizures frequency (48-h video-EEG monitoring; primary efficacy variable) was 43.1% for levetiracetam [modified ITT (mITT) = 58] versus 19.6% for placebo (mITT = 51; p=0.013), with odds ratio for response 3.11 [95% confidence interval (CI), 1.22-8.26]. The median percent reduction from baseline in average daily partial-onset seizure frequency was 43.6% for levetiracetam and 7.1% for placebo with a median difference between treatment groups of 39.2% (95% CI, 17.5-62.2; p < 0.001). In general, levetiracetam was well tolerated. Treatment-emergent adverse events were reported by 55.0% levetiracetam- and 44.6% placebo-treated patients (ITT population). The most frequently reported adverse events were somnolence (13.3% levetiracetam, 1.8% placebo) and irritability (11.7% levetiracetam, 0% placebo).
Discussion: Adjunctive levetiracetam is an efficacious and well-tolerated treatment for partial-onset seizures in infants and young children.
Source: PubMed