title: A multicenter, randomized, placebo-controlled trial of levetiracetam in children and adolescents with newly diagnosed absence epilepsy.
abstract: OBJECTIVE
  To evaluate the potential efficacy of levetiracetam as an antiabsence agent in children and adolescents with newly diagnosed childhood or juvenile absence epilepsy.
  
  
  METHODS
  Patients were randomized in a 2:1 ratio to receive de novo monotherapy with levetiracetam (up to 30 mg/kg/day) or placebo for 2 weeks under double-blind conditions. Responder status (primary end point) was defined as freedom from clinical seizures on days 13 and 14 and from electroencephalographic (EEG) seizures during a standard EEG recording with hyperventilation and intermittent photic stimulation on day 14. The double-blind phase was followed by an open-label follow-up.
  
  
  RESULTS
  Nine of 38 patients (23.7%) were responders in the levetiracetam group, compared with one of 21 (4.8%) in the placebo group (p = 0.08). Seven of 38 patients (18.4%) were free from clinical and EEG seizures during the last 4 days of the trial (including 24-h EEG monitoring on day 14) compared with none of the patients treated with placebo (p = 0.04). Seventeen patients remained seizure-free on levetiracetam after 1 year follow-up. Of the 41 patients who discontinued levetiracetam due to lack of efficacy (n = 39) or adverse events (n = 2), 34 became seizure-free on other treatments.
  
  
  CONCLUSIONS
  Although superiority to placebo just failed to reach statistical significance for the primary end point, the overall findings are consistent with levetiracetam having modest efficacy against absence seizures. Further controlled trials exploring larger doses and an active comparator are required to determine the role of levetiracetam in the treatment of absence epilepsy.
authors.affiliation: IRCCS National Neurological Institute Casimiro Mondino Foundation, Pavia, Italy.
authors.forename: Cinzia
authors.initials: C
authors.lastname: Fattore
authors.forename: Clementina
authors.initials: C
authors.lastname: Boniver
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Capovilla
authors.forename: Caterina
authors.initials: C
authors.lastname: Cerminara
authors.forename: Antonietta
authors.initials: A
authors.lastname: Citterio
authors.forename: Giangennaro
authors.initials: G
authors.lastname: Coppola
authors.forename: Paola
authors.initials: P
authors.lastname: Costa
authors.forename: Francesca
authors.initials: F
authors.lastname: Darra
authors.forename: Marilena
authors.initials: M
authors.lastname: Vecchi
authors.forename: Emilio
authors.initials: E
authors.lastname: Perucca
mesh_terms: D000293:Adolescent; D000367:Age Factors; D000927:Anticonvulsants / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004351:Drug Resistance / Q000502:physiology; D004832:Epilepsy, Absence / Q000188:drug therapy*; D005260:Female; D006801:Humans; D000077287:Levetiracetam; D008297:Male; D017063:Outcome Assessment, Health Care / Q000379:methods; D010889:Piracetam / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*
chemical_list: D000927:Anticonvulsants; D000077287:Levetiracetam; D010889:Piracetam