New evidence continues to demonstrate the efficacy and tolerability of lacosamide in children and adolescents with focal seizures.
An international trial of more than 300 patients aged 4 to 17 years from over 100 sites has shown the drug reduces focal seizure frequency compared to placebo.
The patients all had a confirmed diagnosis of epilepsy with focal seizures uncontrolled despite two or more antiepileptic drugs and at least two seizures during the 8-week prospective baseline period.
Patients in the intervention group received 16 weeks of treatment including a 6-week titration period starting at 2mg/kg/d of oral solution lacosamide for patients <50kg or 100mg/day in tablets for those weighing ≥50kg.
The target dose range for each patient was based on body weight at baseline: 8 to 12 mg/kg/d for <30 kg, 6 to 8 mg/kg/d for ≥30 kg to <50 kg, and 300 to 400 mg/d for ≥50 kg.
The study found the median percent reductions from baseline to maintenance in focal seizure frequency per 28 days were 51.7% for the lacosamide group and 21.7% for the control group.
The proportions of 50% and 75% responders and seizure-free days during the maintenance period were higher with lacosamide than placebo.
Among patients who completed maintenance, 15.1% on lacosamide and 9.7% on placebo were seizure-free.
A subgroup analyses showed similar efficacy of lacosamide in patients with and without concomitant antiepileptic drugs.
Adverse events judged to be drug related were observed in 31.6% of patients on lacosamide and 18.0% of participants on placebo.
Most were of mild to moderate intensity with the most frequent being somnolence and dizziness in the lacosamide group.
The investigators, including Professor Ingrid Scheffer from the University of Melbourne, Austin Health and The Royal Children’s Hospital Melbourne, said the 50% responder rate was consistent with that reported in adults.
“The efficacy of lacosamide observed in children and adolescents in the current trial was in line with that reported for adults with focal seizures,” the study said.
“These results further support the concept of extrapolation of efficacy data from adults to the paediatric population with focal seizures.”
“These data, together with the favourable, predictable pharmacokinetic profile of lacosamide, its low potential for clinically relevant pharmacokinetic drug-drug interactions, and bioequivalent oral (tablets or oral solution) formulations, demonstrate that lacosamide is a valuable addition to the armamentarium of licensed therapies for focal seizures in pediatric patients.”
Lacosamide was PBS listed for the treatment of intractable partial epileptic seizures in children from May this year as part of a $9.2 million funding boost for childhood epilepsy.