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