Original ArticleSafety of levetiracetam among infants younger than 12 months - Results from a European multicenter observational study

•Prospective study evaluating levetiracetam oral solution safety in infants ≤11 months.•Infants with different seizure types treated according to routine clinical practice.•Levetiracetam was well tolerated - no new safety concerns were identified.•Most infants (72%) showed improvement in their condition at study end.•Levetiracetam may be a suitable option for the treatment of infants with epilepsy.

BackgroundThere are limited data on the use of the antiepileptic drug (AED) levetiracetam for the treatment of infants.AimTo prospectively evaluate the safety of levetiracetam oral solution and its impact on epilepsy severity in infants with different seizure types.MethodsThis noninterventional post-authorization safety study included patients 1-11 months of age. Patients' treatment - levetiracetam dose, and addition, withdrawal or changes in the doses of concomitant medications and AEDs - was at the discretion of the physician. The primary variable was treatment-emergent adverse events (TEAEs).ResultsOf 101 infants, 75 completed and 26 discontinued the study. Mean age was 6.0 months, 50 were male, most (80%) took 1 ≥ concomitant AED and had cryptogenic or symptomatic epilepsy that was focal (38.6%) or generalized (20.8%), particularly frontal lobe epilepsy (20.0%) or West syndrome/infantile spasms (20.0%). Among known aetiologies, congenital factors (22.8%) such as dysplastic lesions or perinatal events (17.8%) were predominant. Overall, 54.5% of patients had ≥1 TEAE. Five patients experienced drug-related TEAEs - convulsion, irritability, somnolence and hypotonia, all listed in the product label, with the exception of hypotonia, which was reported for one patient and resolved without any change in study medication. Seven patients discontinued due to TEAEs, mainly due to infantile spasms and respiratory disorders. At study end, 71.8% of patients showed improvement in epilepsy severity, 18.8% remained stable and 9.4% showed worsening. Levetiracetam did not appear to have a negative effect on growth parameters.ConclusionIn this prospective study, which included the largest number of patients in this age range so far, levetiracetam was found to be well tolerated and efficacious for the treatment of infants with epilepsy.