Safety and tolerability of adjunctive lacosamide in a pediatric population with focal seizures – An open-label trial
© 2019 The Authors
Purpose: To evaluate safety and tolerability of adjunctive lacosamide in children with focal seizures.
Methods: Patients were eligible for this open-label, fixed-titration trial (SP0847; NCT00938431) if aged 1 month–17 years with focal seizures taking 1–3 antiepileptic drugs. Findings from Cohort 1, aged 5–11 years, who received lacosamide ≤8 mg/kg/day, informed dosing for age-based cohorts 2–5, who then received ≤12 mg/kg/day (≤600 mg/day). Oral lacosamide was initiated at 2 mg/kg/day (1 mg/kg bid) and uptitrated by 2 mg/kg/day/week to the maximum cohort-defined dose (maximum trial duration: 13 weeks). Patients who did not achieve the maximum cohort-defined dose were discontinued.
Results: Forty-seven patients (aged 6 months–≤17 years) enrolled (≥1 month–= 15; ≥4–= 23; ≥12–≤17 years: n = 9). 24/47 (51.1%) patients completed the trial at the maximum cohort-defined dose and 40/47 (85.1%) continued lacosamide in the extension trial. Treatment-emergent adverse events (TEAEs) were reported by 42/47 (89.4%) patients. The most common TEAEs (≥10% of patients) were vomiting (21.3%), diarrhea (14.9%), somnolence (12.8%), irritability, dizziness, and pyrexia (10.6% each). Twenty (42.6%) patients discontinued due to TEAEs, most commonly vomiting (8.5%), gait disturbance, dizziness, and somnolence (6.4% each). Six (12.8%) patients reported serious TEAEs, most commonly status epilepticus (3/47; 6.4%).
Conclusion: This fixed-titration trial supports the safety of adjunctive lacosamide in children (aged 6 months–≤17 years) with focal seizures. The TEAE profile was generally consistent with that observed in trials in adults, and no new safety concerns were identified.
Antiepileptic, Children, Dosing, Efficacy, Seizure, Titration
Ferreira, J., LePichon, J., Abdelmoity, A., Dilley, D., Dedeken, P., Daniels, T., Byrnes, W. Safety and tolerability of adjunctive lacosamide in a pediatric population with focal seizures – An open-label trial Seizure 71, 166-173 (2019).