(774): A multi-center, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of lacosamide (200, 400, and 600mg/day) in subjects with painful distal diabetic neuropathy

Abstract

Lacosamide (SPM 927) is being investigated as a possible anticonvulsant drug with potential for reducing diabetic neuropathic pain. In a previous pilot trial in subjects with moderate to severe painful diabetic neuropathy, lacosamide administered at 400mg/day for 4 weeks demonstrated a statistically significant reduction in pain as compared to placebo. In order to confirm these results, the efficacy and safety of lacosamide at doses of 200, 400, and 600mg/day were investigated in this double-blind, placebo-controlled, multi-center trial. Subjects with distal diabetic neuropathy ranging in duration from 6 months to 5 years were randomized to receive placebo, 200mg/day, 400mg/day, or 600mg/day lacosamide in a 1:2:2:2 ratio, respectively. After a 2-week run-in, subjects entered a 6-week titration in which subjects titrated to their assigned dose in 100mg/day weekly increments then entered 12-weeks maintenance. No dose adjustments were allowed during the trial. The primary variable was change in average daily pain score from the baseline week to the last 4 weeks of the maintenance phase based on a 0-10 point Likert scale. Secondary variables included assessment of pain at each clinic visit using a 100mm visual analog scale (VAS), assessments of pain interference with subjects′ sleep and activity, quality of life, and global impression of change in pain (PGIC). Adverse events were assessed and recorded throughout the trial. A total of 468 subjects (266 male and 202 female) were randomized at 79 sites in the US and received at least one dose of trial medication. Sixty-seven percent (67%) of subjects were< 65 and 33% were≥ 65 years of age. Efficacy results for each treatment group are presented in the poster. Based on preliminary safety information, the most frequently reported adverse events were dizziness, headache, nausea, tremor, and diarrhea. Supported by grants from Schwarz Biosciences, Inc. Lacosamide (SPM 927) is being investigated as a possible anticonvulsant drug with potential for reducing diabetic neuropathic pain. In a previous pilot trial in subjects with moderate to severe painful diabetic neuropathy, lacosamide administered at 400mg/day for 4 weeks demonstrated a statistically significant reduction in pain as compared to placebo. In order to confirm these results, the efficacy and safety of lacosamide at doses of 200, 400, and 600mg/day were investigated in this double-blind, placebo-controlled, multi-center trial. Subjects with distal diabetic neuropathy ranging in duration from 6 months to 5 years were randomized to receive placebo, 200mg/day, 400mg/day, or 600mg/day lacosamide in a 1:2:2:2 ratio, respectively. After a 2-week run-in, subjects entered a 6-week titration in which subjects titrated to their assigned dose in 100mg/day weekly increments then entered 12-weeks maintenance. No dose adjustments were allowed during the trial. The primary variable was change in average daily pain score from the baseline week to the last 4 weeks of the maintenance phase based on a 0-10 point Likert scale. Secondary variables included assessment of pain at each clinic visit using a 100mm visual analog scale (VAS), assessments of pain interference with subjects′ sleep and activity, quality of life, and global impression of change in pain (PGIC). Adverse events were assessed and recorded throughout the trial. A total of 468 subjects (266 male and 202 female) were randomized at 79 sites in the US and received at least one dose of trial medication. Sixty-seven percent (67%) of subjects were< 65 and 33% were≥ 65 years of age. Efficacy results for each treatment group are presented in the poster. Based on preliminary safety information, the most frequently reported adverse events were dizziness, headache, nausea, tremor, and diarrhea. Supported by grants from Schwarz Biosciences, Inc.