Efficacy and safety of lacosamide in infants and young children with refractory focal epilepsy

Eur J Paediatr Neurol. 2014 Jan;18(1):55-9. doi: 10.1016/j.ejpn.2013.08.006. Epub 2013 Oct 3.

Abstract

Background: Lacosamide is effective and well-tolerated antiepileptic drug (AED) in both children and adults.

Aim: This multicentric, prospective study investigates the efficacy and safety of lacosamide adjunctive therapy in children aged less than four years presenting with refractory focal seizures.

Methods: Lacosamide was added to the baseline therapy at a starting dose of 1-2 mg/kg/day and titrated to the final dose, ranging from 7 to 15.5 mg/kg/day. Efficacy was evaluated after a three-month period of therapy. When possible, we compared the initial efficacy and the retention after a minimum of 12 months of lacosamide, with regard to loss of efficacy (defined as the return to the baseline seizure frequency).

Results: Twenty-four children were enrolled in the study. Mean age was 2.7 years. After a minimum three-month period of lacosamide add-on therapy, ten (42%) patients were responders (more than a 50% decrease in seizure frequency), of whom 4 (17%) became seizure free. Retention rate, after a minimum of 12 months of lacosamide, was evaluated in a group of 18 patients. In the latter group, eight patients (44%) were initial responders (three of whom seizure free). After 12 months of follow-up, four of them (22%) maintained the improvement, 2 (11%) of whom remained seizure free. A loss of efficacy was observed in 4 of the initial responders (50%). Adverse events were seen in 8 (33%) patients.

Conclusion: We conclude that lacosamide is an effective and a well-tolerated antiepileptic drug in an etiologically wide range of focal seizures. Therefore, lacosamide might represent a possible therapeutic option in infants and young children affected by uncontrolled focal epilepsy.

Keywords: Antiepileptic drugs; Drug resistant epilepsy; Epileptic encephalopathy; Partial seizures; Pediatrics.

Publication types

  • Multicenter Study

MeSH terms

  • Acetamides / administration & dosage
  • Acetamides / adverse effects
  • Acetamides / pharmacology*
  • Anticonvulsants / administration & dosage
  • Anticonvulsants / adverse effects
  • Anticonvulsants / pharmacology*
  • Child, Preschool
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Epilepsies, Partial / drug therapy*
  • Epilepsies, Partial / physiopathology
  • Female
  • Follow-Up Studies
  • Humans
  • Infant
  • Lacosamide
  • Male
  • Prospective Studies
  • Seizures / drug therapy*
  • Severity of Illness Index
  • Time Factors
  • Treatment Outcome

Substances

  • Acetamides
  • Anticonvulsants
  • Lacosamide