title: Levetiracetam in children with refractory epilepsy: a multicenter open label study in Germany.
abstract: OBJECTIVE
  To evaluate the efficacy and tolerability of Levetiracetam (LEV) in a large pediatric cohort with drug-resistant epilepsy from a prospective multicenter observational study.
  
  
  METHODS
  We report the results of a multicenter observational survey of a cohort of 285 pediatric patients (mean: 9.9 years, range: 0; 6-17; 11) with refractory generalized and focal epilepsy who received Levetiracetam as an add-on open label treatment trial. The average duration of epilepsy was 6.0 years and the patients were treated with a mean of 7.0 antiepileptic drugs (AED) before LEV was introduced.
  
  
  RESULTS
  No serious persistent adverse events were reported. Reversible colitis and an apnoea syndrome in a child with phosphorylase-A-kinase-deficiency were noted. Mild to moderate side effects were reported in 128 patients (44.9%), consisting most frequently of somnolence (23.9%), general behavioral changes (15.4%), aggression (10.5%) and sleep disturbances (3.2%). In 209 patients, efficacy was analyzed over a treatment period of at least 12 weeks compared to a baseline of 2 weeks. Thirteen patients (6.2%) became seizure free, 39 (18.7%) responded with a seizure reduction of more than 50% following introduction of LEV. No response to LEV was reported in 65.1% (n=136). A decrease of initial treatment effect was seen in 37 patients (17.8%) while in 6.7% the seizure frequency doubled to the baseline (n=14). In seven patients (3.3%), the effect of LEV on seizure frequency could not be evaluated. A positive psychotropic effect was observed in 18 patients (8.6%). Mental retardation was associated with poor response and associated with more side effects and earlier discontinuation of LEV therapy.
  
  
  CONCLUSIONS
  LEV is a well-tolerated new AED that may effectively improve seizure control as an add-on drug in resistant epilepsy in childhood with good tolerability. However, neurologically handicapped children appear at increased risk for reversible neurocognitive side effects and have a poorer treatment response.
authors.affiliation: Evangelisches Krankenhaus, Department of Neuropediatrics, Oberhausen, Germany.
authors.forename: Joachim
authors.initials: J
authors.lastname: Opp
authors.forename: Ingrid
authors.initials: I
authors.lastname: Tuxhorn
authors.forename: Theodor
authors.initials: T
authors.lastname: May
authors.forename: Gerhard
authors.initials: G
authors.lastname: Kluger
authors.forename: Adelheid
authors.initials: A
authors.lastname: Wiemer-Kruel
authors.forename: Gerd
authors.initials: G
authors.lastname: Kurlemann
authors.forename: Gunther
authors.initials: G
authors.lastname: Gross-Selbeck
authors.forename: Dietz
authors.initials: D
authors.lastname: Rating
authors.forename: Ulrich
authors.initials: U
authors.lastname: Brandl
authors.forename: Ulrich
authors.initials: U
authors.lastname: Bettendorf
authors.forename: Christoph
authors.initials: C
authors.lastname: Härtel
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Korn-Merker
mesh_terms: D000927:Anticonvulsants / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D003710:Demography; D004341:Drug Evaluation; D004359:Drug Therapy, Combination; D004827:Epilepsy / Q000188:drug therapy* / Q000453:epidemiology; D005260:Female; D005858:Germany / Q000453:epidemiology; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D000077287:Levetiracetam; D008297:Male; D010889:Piracetam / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011446:Prospective Studies; D012189:Retrospective Studies; D016037:Single-Blind Method; D016896:Treatment Outcome
chemical_list: D000927:Anticonvulsants; D000077287:Levetiracetam; D010889:Piracetam