In pooled efficacy analysis, primary efficacy was evaluated among patients treated with 400mg/day of lacosamide by examining the change in average daily pain score, from baseline to the last four weeks of maintenance in three, Phase III, fixed-dose trials (SP742, SP743, and SP768) and from baseline through the entire maintenance period in one Phase II, flexible-dose trial (SP614).
The mean reduction in pain score reached the level of statistical significance in SP614, SP742 and SP768 (p=0.039, 0.01 and 0.0507, respectively). Significance was not reached for the primary endpoint in SP743, likely due to a strong placebo effect at the final visit.
In pooled safety analysis trials, the overall percentage of patients who discontinued treatment due to adverse events was similar between the placebo group and the lacosamide 200 and 400mg/day groups (24.7%, 29.9% and 32.9%, respectively). The percentage was higher (55.4%) in the group receiving 600mg/day of lacosamide.