title: Efficacy and safety of levetiracetam: an add-on trial in children with refractory epilepsy.
abstract: The aim of this multicentric, prospective and uncontrolled study was to evaluate the efficacy and safety of levetiracetam in 110 children with refractory epilepsy, of whom 21 were less than 4 years old. After a median follow-up period of 7 months, levetiracetam administration was effective (responders with >50% decrease in seizure frequency) in 39% of children, of whom 10 (9%) became seizure-free. The efficacy was higher in patients with localization-related epilepsy (58% of responders) than in those with generalized epilepsy (37% of responders). Levetiracetam was well tolerated. The main side effects of somnolence and irritability occurred in 14% of patients. In one patient acute choreoathetosis occurred after few doses of levetiracetam. Overall, the adverse effects were not severe. Children younger than 4 years were particularly tolerant. In conclusion, the present study confirms that levetiracetam is effective and well tolerated as an add-on treatment in children with refractory epilepsy. Our preliminary data also indicate that levetiracetam may be a valid therapeutic option for epilepsy in infants and young children.
authors.affiliation: Pediatrics Department, University of Siena, Ospedale Santa Maria alle Scotte, Via M. Bracci, 53100 Siena, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Grosso
authors.forename: E
authors.initials: E
authors.lastname: Franzoni
authors.forename: G
authors.initials: G
authors.lastname: Coppola
authors.forename: P
authors.initials: P
authors.lastname: Iannetti
authors.forename: A
authors.initials: A
authors.lastname: Verrotti
authors.forename: D M
authors.initials: DM
authors.lastname: Cordelli
authors.forename: V
authors.initials: V
authors.lastname: Marchiani
authors.forename: A
authors.initials: A
authors.lastname: Pascotto
authors.forename: A
authors.initials: A
authors.lastname: Spalice
authors.forename: B
authors.initials: B
authors.lastname: Acampora
authors.forename: G
authors.initials: G
authors.lastname: Morgese
authors.forename: P
authors.initials: P
authors.lastname: Balestri
mesh_terms: D000927:Anticonvulsants / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004341:Drug Evaluation; D004359:Drug Therapy, Combination; D004569:Electroencephalography; D004827:Epilepsy / Q000145:classification / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D000077287:Levetiracetam; D008297:Male; D009460:Neurologic Examination; D010889:Piracetam / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D011446:Prospective Studies; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D000927:Anticonvulsants; D000077287:Levetiracetam; D010889:Piracetam