The study results suggested a greater percentage of seizure-free days during the first week of exposure to lacosamide (all doses combined) relative to placebo. During the treatment period of the study, there was also a difference between lacosamide and placebo. Additional studies are warranted.
3.234 Evaluation of Long-Term Treatment with Lacosamide for Partial-Onset Seizures in the Elderly
The prevalence of new-onset seizures in the elderly is highest among any age group. As the elderly often take concomitant drugs for other chronic conditions, treatment decisions for epilepsy in this patient population can be challenging. Consequently, a sub-group analysis was performed to compare lacosamide's safety and efficacy profile among elderly patients in three open label trials with the overall patient population. Across three open-label extension trials, which assessed lacosamide exposure for up to eight years, 33 patients were
65 years of age by study end. The median modal dose of lacosamide in this group was 400 mg/day for a mean duration of 1,563.2 days up to a maximum duration of 2,790 days (~7.6 years). Among these patients, the safety and efficacy profile of lacosamide was consistent with the findings observed in the total population of 1,054 patients who initiated open-label lacosamide treatment. Treatment with lacosamide was associated with a reduction in seizure frequency during the study period.
The most commonly reported treatment-emergent adverse events (
15%) were dizziness (36.4%), fall (27.3%), contusion or sinusitis (21.2% each), cognitive disorder, tremor, headache, depression or cough (18.2% each), and urinary tract infection, nausea, diplopia, vision blurred, convulsion, balance disorder, or pain in extremity (15.2% each).
Prospective evaluations still need to be conducted.
Open-Label Pilot Study of Adjunctive Lacosamide for Uncontrolled Primary Generalized Tonic-Clonic Seizures
This Phase II multicenter open-label pilot study is the first assessment of the safety of adjunctive lacosamide for uncontrolled PGTCS in adults with idiopathic generalized epilepsy. The 13-week study included a total of 49 patients, the majority (69.4%) of whom were taking two to three concomitant AEDs at baseline. Lacosamide dose titration started at 100 mg/day (50mg bid) and increased weekly to a maximum of 400 mg/day.