With a standard titration regimen, the trial met its primary objective with sustained and statistically significant reduction in average daily pain scores.
The trial in 551 patients with diabetic neuropathic pain was designed to evaluate the efficacy and safety of lacosamide (400mg per day) in two different titration schemes: a standard titration regimen in which patients reached their target dose at day 22, and a fast titration scheme in which the target dose was reached at day eight.
The primary efficacy results showed that the change in the average daily pain score as measured from baseline to the last four weeks of the 12-week maintenance period was significantly greater with lacosamide 400mg per day given in standard titration than placebo (p=0.0410). The change in pain score with the lacosamide fast titration regimen was numerically better than placebo but did not reach statistical significance (p=0.2902). The median time to achieve sustainable pain relief was 10 and 11 days for the lacosamide standard and fast titration regimens, respectively, compared with 31 days for the placebo group.
Lacosamide was generally well tolerated. The incidences of adverse events were higher in the lacosamide fast titration group than in the standard titration group. The most common adverse events (>=5%) in this trial were dizziness, nausea, headache, nasopharyngitis and vertigo.