title: Long-term adjunctive lacosamide treatment in patients with partial-onset seizures.
abstract: OBJECTIVE
  To evaluate long-term (up to 5.5 years) safety, seizure reduction, and maintenance of efficacy of the antiepileptic drug (AED) lacosamide as adjunctive treatment in an open-label extension trial (SP774; ClinicalTrials.gov: NCT00515619).
  
  
  METHODS
  Three hundred and seventy-six adults with partial-onset seizures taking 1-3 AEDs enrolled following completion of a double-blind trial of adjunctive lacosamide. During open-label treatment, dosage of lacosamide (100-800 mg/day) and/or concomitant AEDs could be adjusted to optimize tolerability and seizure control.
  
  
  RESULTS
  Kaplan-Meier estimates of patient retention were 74.5% at 12 months, 52.9% at 36 months, and 40.6% at 60 months; median open-label treatment duration was 1183 days (~3.2 years). The most frequently reported treatment-emergent adverse events were dizziness (24.2%), headache (14.4%), diplopia (13.8%), and nasopharyngitis (13.8%); 9.0% of patients discontinued due to adverse events, most commonly dizziness (1.3%). Median percent reduction in 28-day seizure frequency from baseline of the double-blind trial was 49.9% overall, 55.4% for 1-year completers, and 62.3% for 3-year completers. Overall, 50.0% of patients were considered ≥50% responders (achieved ≥50% reduction in 28-day seizure frequency); 55.9% of 1-year completers and 63.0% of 3-year completers were ≥50% responders.
  
  
  CONCLUSIONS
  In eligible patients who entered the open-label extension trial, lacosamide was generally well tolerated. For most patients within each yearly completer cohort, seizure reduction was maintained over time.
authors.affiliation: Epilepsy Center Frankfurt Rhine-Main, Center of Neurology and Neurosurgery, Goethe University, Frankfurt a. M, Germany.
authors.forename: F
authors.initials: F
authors.lastname: Rosenow
authors.affiliation: National Institute of Neurosciences, Budapest, Hungary.
authors.forename: A
authors.initials: A
authors.lastname: Kelemen
authors.affiliation: Institute of Clinical Neurosciences, Division of Neurology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
authors.forename: E
authors.initials: E
authors.lastname: Ben-Menachem
authors.affiliation: UCB Pharma, Raleigh, NC, USA.
authors.forename: C
authors.initials: C
authors.lastname: McShea
authors.affiliation: UCB Pharma, Raleigh, NC, USA.
authors.forename: J
authors.initials: J
authors.lastname: Isojarvi
authors.affiliation: UCB Pharma, Raleigh, NC, USA.
authors.forename: P
authors.initials: P
authors.lastname: Doty
keywords: lacosamide; open label; partial-onset seizures; responders; safety; tolerability