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Adjunctive levetiracetam in infants and young children with refractory partial‐onset seizures
Author(s) -
PiñaGarza Jesus Eric,
Nordli Jr Douglas R.,
Rating Dietz,
Yang Haichen,
SchiemannDelgado Jimmy,
Duncan Benjamin
Publication year - 2009
Publication title -
epilepsia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.687
H-Index - 191
eISSN - 1528-1167
pISSN - 0013-9580
DOI - 10.1111/j.1528-1167.2008.01981.x
Subject(s) - levetiracetam , tolerability , medicine , placebo , anesthesia , pediatrics , randomized controlled trial , population , adverse effect , epilepsy , psychiatry , alternative medicine , environmental health , pathology
Summary 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 ≥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.