title: Prospective Open-Label, Single-Arm, Multicenter, Safety, Tolerability, and Pharmacokinetic Studies of Intravenous Levetiracetam in Children With Epilepsy.
abstract: Levetiracetam given via intravenous administration has been shown to be an effective alternative in adults with epilepsy when oral administration is not feasible. This study was a prospective single-arm, multicenter study to assess tolerability, safety, and pharmacokinetics of intravenous levetiracetam in children with epilepsy. Children with epilepsy ages 1 month to 16 years requiring intravenous levetiracetam were enrolled. Assessments included vital signs, electrocardiogram, hematology, chemistry, plasma concentrations of antiepileptic medications, weight, physical/neurological examinations, and pharmacokinetics. A total of 52 patients were enrolled. Mild to moderate treatment-emergent adverse events occurred in 63%, the most frequent being pyrexia and dry mouth. Most other treatment-emergent adverse events were considered unrelated to intravenous levetiracetam administration. Therefore, intravenous levetiracetam in the acute setting was overall well tolerated in children 1 month to 16 years.
authors.affiliation: 1State University of New York at Buffalo, Buffalo, NY, USA.
authors.forename: Arie
authors.initials: A
authors.lastname: Weinstock
authors.forename: Matilde
authors.initials: M
authors.lastname: Ruiz
authors.forename: Danielle
authors.initials: D
authors.lastname: Gerard
authors.forename: Nathalie
authors.initials: N
authors.lastname: Toublanc
authors.forename: Armel
authors.initials: A
authors.lastname: Stockis
authors.forename: Osman
authors.initials: O
authors.lastname: Farooq
authors.forename: Deanne
authors.initials: D
authors.lastname: Dilley
authors.forename: Yuval
authors.initials: Y
authors.lastname: Karmon
authors.forename: Mary Jo
authors.initials: MJ
authors.lastname: Elgie
authors.forename: Jimmy
authors.initials: J
authors.lastname: Schiemann-Delgado
keywords: epilepsy; intravenous; levetiracetam; pharmacokinetics