title: An open-label trial of levetiracetam in severe myoclonic epilepsy of infancy.
abstract: OBJECTIVE
  To conduct an open-label, add-on trial on safety and efficacy of levetiracetam in severe myoclonic epilepsy of infancy (SMEI).
  
  
  METHODS
  SMEI patients were recruited from different centers according to the following criteria: age > or =3 years; at least four tonic-clonic seizures/month during the last 8 weeks; previous use of at least two drugs. Levetiracetam was orally administrated at starting dose of approximately 10 mg/kg/day up to 50 to 60 mg/kg/day in two doses. Treatment period included a 5- to 6-week up-titration phase and a 12-week evaluation phase. Efficacy variables were responder rate by seizure type and reduction of the mean number per week of each seizure type. Analysis was performed using Fisher exact and Wilcoxon tests.
  
  
  RESULTS
  Twenty-eight patients (mean age: 9.4 +/- 5.6 years) entered the study. Sixteen (57.1%) showed SCN1A mutations. Mean number of concomitant drugs was 2.5. Mean levetiracetam dose achieved was 2,016 mg/day. Twenty-three (82.1%) completed the trial. Responders were 64.2% for tonic-clonic, 60% for myoclonic, 60% for focal, and 44.4% for absence seizures. Number per week of tonic-clonic (median: 3 vs 1; p = 0.0001), myoclonic (median: 21 vs 3; p = 0.002), and focal seizures (median: 7.5 vs 3; p = 0.031) was significantly decreased compared to baseline. Levetiracetam effect was not related to age at onset and duration of epilepsy, genetic status, and concomitant therapy. Levetiracetam was well tolerated by subjects who completed the study. To date, follow-up ranges 6 to 36 months (mean, 16.2 +/- 13.4).
  
  
  CONCLUSIONS
  Levetiracetam add-on is effective and well tolerated in severe myoclonic epilepsy of infancy. Placebo-controlled studies should confirm these findings.
authors.affiliation: Epilepsy Center, Federico II University, Napoli, Italy. pstriano@email.it
authors.forename: P
authors.initials: P
authors.lastname: Striano
authors.forename: A
authors.initials: A
authors.lastname: Coppola
authors.forename: M
authors.initials: M
authors.lastname: Pezzella
authors.forename: C
authors.initials: C
authors.lastname: Ciampa
authors.forename: N
authors.initials: N
authors.lastname: Specchio
authors.forename: F
authors.initials: F
authors.lastname: Ragona
authors.forename: M M
authors.initials: MM
authors.lastname: Mancardi
authors.forename: E
authors.initials: E
authors.lastname: Gennaro
authors.forename: F
authors.initials: F
authors.lastname: Beccaria
authors.forename: G
authors.initials: G
authors.lastname: Capovilla
authors.forename: P
authors.initials: P
authors.lastname: Rasmini
authors.forename: D
authors.initials: D
authors.lastname: Besana
authors.forename: G G
authors.initials: GG
authors.lastname: Coppola
authors.forename: M
authors.initials: M
authors.lastname: Elia
authors.forename: T
authors.initials: T
authors.lastname: Granata
authors.forename: M
authors.initials: M
authors.lastname: Vecchi
authors.forename: F
authors.initials: F
authors.lastname: Vigevano
authors.forename: M
authors.initials: M
authors.lastname: Viri
authors.forename: R
authors.initials: R
authors.lastname: Gaggero
authors.forename: S
authors.initials: S
authors.lastname: Striano
authors.forename: F
authors.initials: F
authors.lastname: Zara
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D002675:Child, Preschool; D004831:Epilepsies, Myoclonic / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000077287:Levetiracetam; D008297:Male; D010889:Piracetam / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000077287:Levetiracetam; D010889:Piracetam