Abstract
To evaluate efficacy and safety of the investigational antinociceptive, anticonvulsant drug lacosamide in the treatment of diabetic neuropathic pain, data from Phase II and III double-blind, randomized, placebo-controlled trials were evaluated. Three fixed-dose trials (SP742, SP743, SP768) consisted of a 12-week maintenance phase in which participants were administered 200, 400 or 600 mg/day lacosamide or placebo. A Phase II flexible-dose trial (SP614), in which patients were allowed a maximum of 400mg/day lacosamide or placebo, consisted of a 4-week maintenance phase.
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