title: Safety of lacosamide in children with refractory partial epilepsy.
abstract: OBJECTIVE
  The study was carried out to investigate the safety of lacosamide on children with refractory partial epilepsy.
  
  
  METHODS
  The study was carried out at a tertiary care hospital after obtaining approval from the institutional ethics committee. Patients aged between 5 and 15 years taking oral lacosamide (LCM) tablets that were given orally as an adjunctive anti-epileptic drug were enrolled for assessing safety, tolerability and its effect on the behavioural life at every visit of titration, during the treatment period (3 months) and at 2 follow up visits that were done at monthly intervals. Adverse events reported by caregiver or by investigator were recorded. Patients/caregivers also completed a 25 items on Connor's behavioural rating clinical scale at every visit.
  
  
  RESULTS
  Out of 531 screened patients, 79 patients with refractory partial epilepsy were enrolled after they fulfilled the inclusion and exclusion criteria. Mean age of the children was 8.84 ± 3.09 years (5-15 years), of which 53 were males and 26 females. The mean age at onset of seizures in males was 6.46 ± 3.57 and in females, 6.38 ± 3.39 years. Seventy-six children of 79, completed 3 months of treatment period showed significant (p < 0.001) decrease in the frequency of seizures, significant improvement in behaviour and showed good tolerability. Three (3.79%) patients dropped out of the study due to hyperactive behaviour, vomiting and lack of seizure control respectively.
  
  
  CONCLUSIONS
  Lacosamide is a well-tolerated newer antiepileptic drug that is effective in refractory partial epilepsy paediatric patients and concurrently improved patient's behaviour.
authors.affiliation: Dept. of Pharmacology, KLE University's College of Pharmacy, Belgaum, Karnataka State, India.
authors.forename: Ismail
authors.initials: I
authors.lastname: Pasha
authors.affiliation: Dept. of Pediatric Neurology, KLE University's J N Medical College, KLES Prabhakar Kore Hospital, Belgaum, Karnataka State, India.
authors.forename: Mahesh
authors.initials: M
authors.lastname: Kamate
authors.affiliation: Dept. of Pharmacology, Luqman College of Pharmacy, Jevargi Road, Gulbarga, Karnataka State, India.
authors.forename: D K
authors.initials: DK
authors.lastname: Suresh
keywords: Adverse effects; Behaviour; Hyperactivity; Lacosamide; Refractory partial epilepsy