Belgian drugmaker UCB reported data at the American Academy of Neurology annual meeting in Chicago showing that diabetic neuropathy patients treated with 400mg/day of lacosamide saw a significant mean reduction in pain score in two Phase III, fixed-dose studies (SP742 and SP768) and one Phase II, flexible-dose trial (SP614). According to the firm, a meta-analysis of all Phase III assessments of the agent showed a significant mean reduction in pain score of 2.14 for the lacosamide group compared with a 1.57 drop for placebo (p=0.0006).
The pain score was based on an 11-point Likert Scale ranging from zero (no pain) to 10 (worst possible pain). 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, the firm noted.
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