Data from: Efficacy and tolerability of adjunctive lacosamide in pediatric patients with focal seizures

Objective: To evaluate efficacy and tolerability of adjunctive lacosamide
in children and adolescents with uncontrolled focal (partial-onset)
seizures. Methods: Double-blind trial (SP0969; NCT01921205) of patients
(≥4 to <17 years) with uncontrolled focal seizures, randomized
(1:1) to adjunctive lacosamide/placebo. Following 6-week Titration,
patients who reached the target dose-range for their weight (<30
kg: 8–12 mg/kg/day oral solution; ≥30 to <50 kg: 6–8 mg/kg/day oral
solution; ≥50 kg: 300–400 mg/day tablets) entered a 10-week Maintenance
period. Primary outcome was change in focal seizure frequency/28 days from
Baseline to Maintenance. Results: 343 patients were randomized; 306
(lacosamide: 152/171 [88.9%]; placebo: 154/172 [89.5%]) completed
Treatment (Titration and Maintenance). Adverse events (AEs) were the most
common reasons for discontinuation during Treatment (lacosamide: 4.1%;
placebo: 5.8%). From Baseline to Maintenance, percent reduction in focal
seizure frequency/28 days for lacosamide (N = 170) vs placebo (N = 168)
was 31.7% (p = 0.0003). During Maintenance, median percent reduction in
focal seizure frequency/28 days was 51.7% for lacosamide and 21.7% for
placebo. 50% responder rates (≥50% reduction) were 52.9% and 33.3% (odds
ratio: 2.17; p = 0.0006). During Treatment, treatment-emergent AEs were
reported by 67.8% lacosamide-treated patients (placebo: 58.1%), most
commonly (≥10%) somnolence (14.0%; placebo: 5.2%) and dizziness (10.5%;
3.5%). Conclusions: Adjunctive lacosamide was efficacious in reducing
seizure frequency and generally well tolerated in patients (≥4 to
<17 years) with focal seizures. Classification of evidence: This
trial provides Class I evidence that for children and adolescents with
uncontrolled focal seizures, adjunctive lacosamide reduces seizure
frequency.