Multicenter, rater-blind, randomized, age-stratified, parallel-group study comparing low-dosage (10 mg/kg/day) versus high-dosage (60 mg/kg/day) TRILEPTAL as adjunctive therapy in 128 pediatric patients aged 1 month to 4 years still experiencing partial seizures while taking up to 2 AEDs. Patients on a low dosage remained in the study for 9 days; and patients on a high dosage, for 35 days. The chart above represents a subanalysis of patients aged 24 months to <48 months (n=41). Patients experienced at least 2 Study Seizure Type 1 (SST1) seizures during the baseline period. The seizure was required to have an electroencephalogram (EEG) lasting at least 20 seconds, as well as behavioral manifestations. Partial seizure frequency is calculated as the number of SST1 seizures experienced during continuous video-EEG monitoring in the treatment phase, divided by the length of the period in hours and multiplied by 24 hours. There was no evidence that TRILEPTAL was effective in patients <2 years.1
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For pediatric patients aged 24 to <48 months, a reduction of 6.68 partial seizures per 24-hour period (P=.020) was observed with a high dosage of TRILEPTAL (60 mg/kg/day)1
— This represents a 79% reduction in frequency of partial seizures
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TRILEPTAL was well tolerated in this pediatric patient population1 |
NEXT: See studies on breakthrough partial seizures
References:
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Adult Efficacy
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