title: Efficacy and safety of lacosamide in infants and young children with refractory focal epilepsy.
abstract: BACKGROUND
  Lacosamide is effective and well-tolerated antiepileptic drug (AED) in both children and adults.
  
  
  OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Child Neurology-Immunology and Endocrinology Unit, University of Siena, Italy; Department of Pediatrics, University of Siena, Italy. Electronic address: grosso@unisi.it.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Grosso
authors.affiliation: Child Neurology, Chair of Pediatrics, NESMOS Department, Faculty of Medicine and Psychology, "Sapienza University", Rome, Italy.
authors.forename: Pasquale
authors.initials: P
authors.lastname: Parisi
authors.affiliation: Department of Pediatrics, Child Neurology Division, Sapienza University of Rome, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Spalice
authors.affiliation: Clinical Pediatrics, University of Chieti, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Verrotti
authors.affiliation: Department of Pediatrics, University of Siena, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Balestri
mesh_terms: D000081:Acetamides / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D000927:Anticonvulsants / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D002675:Child, Preschool; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004828:Epilepsies, Partial / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D000078334:Lacosamide; D008297:Male; D011446:Prospective Studies; D012640:Seizures / Q000188:drug therapy*; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000081:Acetamides; D000927:Anticonvulsants; D000078334:Lacosamide
keywords: Antiepileptic drugs; Drug resistant epilepsy; Epileptic encephalopathy; Partial seizures; Pediatrics