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Lacosamide May Provide Treatment Option for Painful Distal Diabetic Neuropathy: Presented at AAN

By Claire Sowerbutt

SAN DIEGO, C.A. -- April 7, 2006 -- A new agent, lacosamide, previously known as SPM 927, has demonstrated significant efficacy and safety for treatment of painful distal diabetic neuropathy, researchers reported here during the 58^th Annual Meeting of the American Academy of Neurology (AAN).

"We saw significant reductions in pain with 400 mg/day of lacosamide treatment," said James Wymer, MD, PhD, medical director, Upstate Clinical Research, Albany, New York, United States, in a poster presentation on April 5^th for the SP742 Study Group

"Lacosamide is a new medication, currently under clinical development for the treatment of epilepsy as well as neuropathic pain. This is 1 of the major studies that evaluates the efficacy of the medication in painful diabetic neuropathy," he said.

Dr. Wymer and researchers from Schwarz Biosciences, Raleigh, North Carolina, United States, and Manheim, Germany, conducted the randomised, double-blind, multicentre, placebo-controlled, dose-finding study to evaluate the twice-daily administration of lacosamide 200 mg/day, 400 mg/day, and 600 mg/day.

In total, 370 patients were randomised in a 1:1:1:1 fashion. Participants had their medication titrated up over the course of 6 weeks, and were then entered into a 12-week maintenance phase, followed by an optional 12-week open-label phase. The maximum duration of treatment per subject was 20 weeks.

Subjects were asked to rate their pain in a diary twice daily using the 11-point Likert pain scale. Adverse events were assessed throughout.

"We found that at the 2 higher doses, there were statistically significant responses," Dr. Wymer said.

The researchers observed a 2.5-point reduction in the Likert Scale, from baseline, in the 400-mg group with lacosamide, a 2.2-point reduction in the 600-mg group, and a 2.1-point reduction in the 200-mg/group. Using the last observation carried forward (LOCF), the difference between 400-mg/day dose and placebo was statistically significant: P = 0.0126.

"The benefits were seen early in the titration and they were sustained through the course of the study," Dr. Wymer said.

With respect to adverse events, 297 (80.3%) of participants experience a minimum of 1 adverse event, and 20% of the study population withdrew due to adverse events, 8.6% in the placebo group, 8.6% in the 200-mg group, 23.1% in the 400-mg group, and 39.8% in the 600-mg group.

"There were minimal side effects," Dr. Wymer said. "With the exception of dizziness which occurred during titration, it was similar to placebo."

"This drug offers us another treatment for diabetic neuropathic pain. It's another medication, with different mechanisms of action, that may be used to treat patients who have failed on other agents," Dr. Wymer said.

The research was supported by funding from Schwarz Biosciences, Raleigh, North Carolina, United States, and Manheim, Germany.


[Presentation title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Efficacy and Safety of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy. Abstract P04.001]

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