A multicenter, randomized, placebo-controlled trial of levetiracetam in children and adolescents with newly diagnosed absence epilepsy.

Abstract

PURPOSE:

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.

KEY FINDINGS:

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.

SIGNIFICANCE:

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: Cinzia Fattore, Clementina Boniver, Giuseppe Capovilla, Caterina Cerminara, Antonietta Citterio, Giangennaro Coppola, Paola Costa, Francesca Darra, Marilena Vecchi, Emilio Perucca
• Journal: Epilepsia (Epilepsia) Vol. 52 Issue 4 Pg. 802-9 (Apr 2011) ISSN: 1528-1167 [Electronic] United States
• PMID: 21320119 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Wiley Periodicals, Inc. © 2011 International League Against Epilepsy.

Chemical References

• Anticonvulsants
• Levetiracetam
• Piracetam

Topics

• Adolescent
• Age Factors
• Anticonvulsants (administration & dosage, adverse effects)
• Child
• Child, Preschool
• Double-Blind Method
• Drug Resistance (physiology)
• Epilepsy, Absence (drug therapy)
• Female
• Humans
• Levetiracetam
• Male
• Outcome Assessment, Health Care (methods)
• Piracetam (administration & dosage, adverse effects, analogs & derivatives)