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Lacosamide in Painful Diabetic Peripheral Neuropathy: A Phase 2 Double-blind Placebo-controlled Study

Rauck, Richard L. MD*; Shaibani, Aziz MD; Biton, Victor MD; Simpson, Jeff PhD§; Koch, Brigitte PhD

doi: 10.1097/01.ajp.0000210957.39621.b2
Original Articles

Background Peripheral diabetic neuropathy affects between 20% and 45% of patients with diabetes.

Objective To ascertain the effect of lacosamide on pain associated with peripheral diabetic neuropathy.

Methods One hundred nineteen patients with a 1 to 5-year history of pain attributed to diabetic neuropathy and a score of ≥4 on the Likert pain scale entered the multicenter, randomized, double-blind, placebo-controlled trial. Lacosamide (N=60) titrated from 100 to 400 mg/d or maximum tolerated dose and placebo (N=59) were the trial interventions. Primary efficacy criterion was change in pain score on the 11-point Likert pain scale. Secondary assessments included Short-Form McGill Pain and Short-Form-36 Quality of Life Questionnaires, sleep/activity interference, pain intensity, Patient and Clinical Global Impression of Change, and Profile of Mood. Patients receiving at least 1 dose of medication underwent safety evaluation.

Results Ninety-four patients (lacosamide 46; placebo 48) completed the trial. Lacosamide had significantly (P=0.039) better pain relief versus placebo (primary outcome). Improvements were also seen in secondary outcome measures. Adverse events occurred in 52 lacosamide and 44 placebo patients. Common adverse events, occurring in ≥5% of patients, were headache (lacosamide 18%, placebo 22%), dizziness (lacosamide 15%, placebo 8%), and nausea (lacosamide 12%, placebo 7%). Five lacosamide and 3 placebo patients withdrew for adverse events.

Discussion Lacosamide seems to attenuate pain in diabetic neuropathy in doses up to 400 mg/d and improves quality of life issues.

*The Center for Clinical Research, Winston-Salem, NC

Nerve and Muscle Center of Texas, Houston, TX

Clinical Trials, Inc, Little Rock, AR

§Therapeutic Area Neurology, Schwarz Biosciences, Inc, RTP, NC

Clinical Operations, Schwarz Biosciences, Inc, Monheim, Germany

Financial Support: Schwarz Pharma AG, Monheim, Germany, provided the trial supplies and Schwarz BioSciences, Inc, Research Triangle Park, NC sponsored and funded the trial.

Reprints: Richard L. Rauck, MD, 145 Kimel Park Drive, Suite 330, Winston-Salem, NC 27103 (e-mail:

Received for publication October 4, 2005; accepted September 18, 2006

© 2007 Lippincott Williams & Wilkins, Inc.