(766): A multi-center, open-label, follow-on trial to assess the long-term safety and efficacy of lacosamide in subjects with painful distal diabetic neuropathy

Abstract

Lacosamide (formerly SPM 927) is being investigated as a possible anticonvulsant with potential effect in reducing diabetic neuropathic pain. This is an open-label, follow-on trial to a previously completed double-blind trial in subjects with painful diabetic neuropathy. Subjects titrate to their optimal dose (100-600mg/day) in weekly increments of 100mg/day then enter a long-term maintenance period. Dose adjustments are allowed as necessary. Morning and evening pain and interference of pain with sleep and activity are assessed by daily diary entries using an 11-point Likert scale. Scores for each visit are summarized by the observed cases method. Adverse events (AEs) are recorded throughout the trial. Two hundred-fourteen (214) subjects enrolled in the trial and received lacosamide. Forty-seven percent (47%) of subjects were female, 79% of subjects were <65 and 21% were >65 years of age. Based on preliminary results, the maximum duration of lacosamide exposure was 518 days and the most commonly prescribed dose was 400mg/day. The number of subjects on treatment for at least 6 or 12 months was 182 and 91, respectively. Marked reductions in the Likert pain score on average among the patients were observed over the whole treatment period. Eighteen (18, 8%) subjects discontinued the trial for adverse events. The most common AEs included dizziness, vertigo, headache, nasopharyngitis, fatigue, and nausea. The poster will present updated and more detailed results from an upcoming analysis. Supported by grants from Schwarz Biosciences GmbH.