The efficacy and tolerability of oral lacosamide (200, 400, and 600 mg/day) was evaluated
in patients with painful diabetic neuropathy in a double-blind, randomized, placebo-controlled
trial. The primary target dose to be confirmed was lacosamide 400 mg/day. Efficacy
was assessed by changes in pain scale scores from baseline, with changes over the
last 4 weeks of the 12-week maintenance period regarded as the primary endpoint. Endpoint
reductions in mean pain score were higher with all doses of lacosamide, reaching the
level of significance with 400 mg/day (P = .05). Over the treatment period (titration
+ maintenance), pain relief was significantly higher than placebo with lacosamide
400 (P = .02) and 600 mg/day (P = .03). Lacosamide had an early-onset effect with
significant reductions over placebo during the titration period. Nonparametric and
mixed-model analysis approaches gave similar results, supporting significant efficacy
at 400 mg/day. Secondary criteria such as Patient's Global Impression of Change, responder
rates, and pain-free days provided additional support. Adverse events included dizziness,
nausea, and headache. Incidence of cognitive and behavioral adverse events was low.
This trial suggests that lacosamide has beneficial effects and may be a suitable treatment
option for patients with diabetic neuropathic pain.
This study presents efficacy and safety results of a phase 3, double-blind, placebo-controlled
trial of the anticonvulsant drug lacosamide in patients with painful diabetic neuropathy.
Lacosamide treatment at a dose of 400 mg/day reduced diabetic neuropathic pain with
a favorable safety and tolerability profile that may be suitable for patients with
diabetes.