title: Efficacy and safety of levetiracetam in children with partial seizures: an open-label trial.
abstract: OBJECTIVE
  To assess the efficacy and safety of levetiracetam (LEV) as adjunctive therapy in children with treatment-resistant partial-onset seizures.
  
  
  METHODS
  Children (aged 6-12 years) with treatment-resistant partial-onset seizures receiving one standard antiepileptic drug (AED) were eligible. After a 4-week baseline period, children received LEV in a 6-week titration phase (target dose, 40 mg/kg/day) followed by an 8-week evaluation phase. Seizure frequency during the evaluation period with individualized LEV doses (20-40 mg/kg/day) were compared with the 4-week baseline seizure frequency. Plasma concentrations of LEV and other AEDs were determined to evaluate potential drug interactions.
  
  
  RESULTS
  Twenty-four subjects enrolled and received LEV; 23 entered the evaluation phase, and 22 completed the evaluation phase. Compared with their baseline seizure frequency, 12 (52%) of 23 subjects entering the evaluation phase had their seizure frequency decrease by >50%. Two subjects remained seizure free during the entire evaluation period. LEV did not significantly affect plasma concentrations of any concomitant AED during this study, and no alteration of mean clinical laboratory values was observed. The most commonly reported adverse events were headache, infection, anorexia, and somnolence.
  
  
  CONCLUSIONS
  This open-label study of adjunctive LEV therapy (at 20-40 mg/kg/day) suggests that LEV is effective, safe, and well tolerated in children ages 6-12 years with treatment-resistant partial-onset seizures. A randomized, placebo-controlled, double-blind trial of LEV adjunctive therapy in children with treatment-resistant partial-onset seizures is needed and ongoing to confirm these open-label findings.
authors.affiliation: Department of Neurology, Children's Hospital Medical Center, Cincinnati, Ohio 45229, USA. glauser@chmcc.org
authors.forename: Tracy A
authors.initials: TA
authors.lastname: Glauser
authors.forename: John M
authors.initials: JM
authors.lastname: Pellock
authors.forename: E Martina
authors.initials: EM
authors.lastname: Bebin
authors.forename: Nathan B
authors.initials: NB
authors.lastname: Fountain
authors.forename: Frank J
authors.initials: FJ
authors.lastname: Ritter
authors.forename: Christof M
authors.initials: CM
authors.lastname: Jensen
authors.forename: W Donald
authors.initials: WD
authors.lastname: Shields
mesh_terms: D000367:Age Factors; D017668:Age of Onset; D000855:Anorexia / Q000139:chemically induced; D000927:Anticonvulsants / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D002648:Child; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004828:Epilepsies, Partial / Q000097:blood / Q000188:drug therapy*; D005260:Female; D006261:Headache / Q000139:chemically induced; D006801:Humans; D007239:Infections / Q000139:chemically induced; D000077287:Levetiracetam; D008297:Male; D010889:Piracetam / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000097:blood / Q000627:therapeutic use*; D012893:Sleep Wake Disorders / Q000139:chemically induced; D016896:Treatment Outcome
chemical_list: D000927:Anticonvulsants; D000077287:Levetiracetam; D010889:Piracetam