Safety and tolerability of adjunctive lacosamide in a pediatric population with focal seizures – An open-label trial

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DOI: 10.1016/j.seizure.2019.05.016


© 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.

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Antiepileptic, Children, Dosing, Efficacy, Seizure, Titration

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