Lacosamide in painful diabetic peripheral neuropathy: a phase 2 double-blind placebo-controlled study

Clin J Pain. 2007 Feb;23(2):150-8. doi: 10.1097/01.ajp.0000210957.39621.b2.


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 > or =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 > or =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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acetamides / adverse effects
  • Acetamides / therapeutic use*
  • Aged
  • Analgesics / adverse effects
  • Analgesics / therapeutic use*
  • Diabetic Neuropathies / drug therapy*
  • Diabetic Neuropathies / physiopathology
  • Double-Blind Method
  • Drug Eruptions / etiology
  • Electrocardiography
  • Female
  • Gastrointestinal Diseases / chemically induced
  • Headache / chemically induced
  • Heart / drug effects
  • Heart / physiopathology
  • Humans
  • Lacosamide
  • Male
  • Middle Aged
  • Pain Measurement
  • Quality of Life
  • Treatment Outcome


  • Acetamides
  • Analgesics
  • Lacosamide