Details

Autor(en) / Beteiligte

• Piña‐Garza, Jesus Eric
• Nordli Jr, Douglas R.
• Rating, Dietz
• Yang, Haichen
• Schiemann‐Delgado, Jimmy
• Duncan, Benjamin

Titel

Adjunctive levetiracetam in infants and young children with refractory partial‐onset seizures

Ist Teil von

• Epilepsia (Copenhagen), 2009-05, Vol.50 (5), p.1141-1149

Ort / Verlag

Oxford, UK: Blackwell Publishing Ltd

Erscheinungsjahr

2009

Quelle

Wiley Online Library Journals Frontfile Complete

Beschreibungen/Notizen

• 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.