title: A long-term open-label extension study assessing cognition and behavior, tolerability, safety, and efficacy of adjunctive levetiracetam in children aged 4 to 16 years with partial-onset seizures.
abstract: The objective of this study was to assess cognition and behavior in children (4-16 years; n = 103) with partial-onset seizures using the Leiter-R International Performance Scale and Achenbach Child Behavior Checklist. The study was a multicenter, open-label, noncomparative 48-week extension study (NCT00152516) of adjunctive levetiracetam (20-100 mg/kg/d, mean 50.2 mg/kg/d). Improvement from baseline in Leiter-R Memory Screen composite score at weeks 24 and 48 (mean [SD] change, +4.8 [12.6] and +4.5 [15.3]) was similar to changes observed with levetiracetam and placebo in a prior study. Child Behavior Checklist Syndrome scores improved from baseline at weeks 24 and 48 (total problems mean [SD] change, -9.3 [22.2] and -10.4 [23.4]). Adjunctive levetiracetam was well tolerated (most frequently reported central nervous system-related treatment-emergent adverse events: headache [24.3%], aggression [7.8%], irritability [7.8%]). Of the patients, 4.9% discontinued because of treatment-emergent adverse events. Levetiracetam provided good and sustained seizure control (median percentage reduction from baseline in partial-onset seizure frequency/wk during maintenance: 86.4%); 24.7% of patients had continuous seizure freedom from all seizure types for ≥40 weeks. In children, adjunctive levetiracetam was associated with long-term stability in cognitive functioning and improvement in emotional/behavioral functioning over time.
authors.affiliation: UCB, Inc, Raleigh, NC 27617, USA. Jimmy.Schiemann@ucb.com
authors.forename: Jimmy
authors.initials: J
authors.lastname: Schiemann-Delgado
authors.forename: Haichen
authors.initials: H
authors.lastname: Yang
authors.forename: Christine de la
authors.initials: Cde L
authors.lastname: Loge
authors.forename: Tracy J
authors.initials: TJ
authors.lastname: Stalvey
authors.forename: John
authors.initials: J
authors.lastname: Jones
authors.forename: Daniel
authors.initials: D
authors.lastname: Legoff
authors.forename: Mark
authors.initials: M
authors.lastname: Mintz
mesh_terms: D000293:Adolescent; D000367:Age Factors; D000927:Anticonvulsants / Q000627:therapeutic use*; D001526:Behavioral Symptoms / Q000188:drug therapy* / Q000209:etiology; D002648:Child; D002675:Child, Preschool; D003072:Cognition Disorders / Q000188:drug therapy* / Q000209:etiology; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004828:Epilepsies, Partial / Q000150:complications / Q000188:drug therapy*; D005260:Female; D006801:Humans; D000077287:Levetiracetam; D008137:Longitudinal Studies; D008297:Male; D009483:Neuropsychological Tests; D010889:Piracetam / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011569:Psychiatric Status Rating Scales; D016896:Treatment Outcome
chemical_list: D000927:Anticonvulsants; D000077287:Levetiracetam; D010889:Piracetam