Adjunctive lacosamide for partial-onset seizures: Efficacy and safety results from a randomized controlled trial

Péter Halász, Reetta Kälviäinen, Maria Mazurkiewicz-Beldzińska, Felix Rosenow, Pamela Doty, David Hebert, Timothy Sullivan

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289 Citations (Scopus)

Abstract

Purpose: To evaluate the efficacy and safety of lacosamide (200 and 400 mg/day) when added to one to three concomitant antiepileptic drugs (AEDs) in patients with uncontrolled partial-onset seizures. Methods: This multicenter, double-blind, placebo-controlled trial randomized patients (age 16-70 years) with partial-onset seizures with or without secondary generalization to placebo, lacosamide 200, or lacosamide 400 mg/day. The trial consisted of an 8-week baseline, a 4-week titration, and a 12-week maintenance period. Results: Four hundred eighty-five patients were randomized and received trial medication. Among these, 87% were taking two or more concomitant AEDs. Median percent reduction in seizure frequency per 28 days from baseline to maintenance period (intent-to-treat, ITT) was 20.5% for placebo, 35.3% for lacosamide 200 mg/day (p = 0.02), and 36.4% for 400 mg/day (p = 0.03). In the per protocol population, the reductions were 35.3% for lacosamide 200 mg/day (p = 0.04) and 44.9% for 400 mg/day (p = 0.01) compared to placebo (25.4%). The 50% responder rate for lacosamide 400 mg/day (40.5%) was significant (p = 0.01) over placebo (25.8%), but was not for 200 mg/day (35.0%). In the per protocol population, the 50% responder rate for lacosamide 400 mg/day (46.3%) was significant (p < 0.01) compared with the placebo responder rate (27.5%). Dose-related adverse events (AEs) included dizziness, nausea, and vomiting. Clinically relevant changes in the mean plasma concentrations of commonly used AEDs were not observed. Discussion: Results of this trial demonstrated the efficacy and tolerability of adjunctive lacosamide 200 and 400 mg/day and support that lacosamide may be an advantageous option for the treatment of partial-onset seizures in patients with epilepsy.

Original languageEnglish
Pages (from-to)443-453
Number of pages11
JournalEpilepsia
Volume50
Issue number3
DOIs
Publication statusPublished - Mar 2009

Keywords

  • Antiepileptic drugs
  • Epilepsy
  • Lacosamide
  • Partial-onset seizures
  • Randomized controlled trial

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology

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  • Cite this

    Halász, P., Kälviäinen, R., Mazurkiewicz-Beldzińska, M., Rosenow, F., Doty, P., Hebert, D., & Sullivan, T. (2009). Adjunctive lacosamide for partial-onset seizures: Efficacy and safety results from a randomized controlled trial. Epilepsia, 50(3), 443-453. https://doi.org/10.1111/j.1528-1167.2008.01951.x