"A significantly greater proportion of subjects in the 400 mg/day and 600 mg/day lacosamide groups reported feeling better at the conclusion of the trial as compared with the placebo group," said lead author James Wymer, neurologist and founding partner of Upstate Clinical Research, Albany, New York.

In the 18-week trial, Dr. Wymer and colleagues evaluated the efficacy and safety of lacosamide in 370 patients with moderate to severe painful distal diabetic neuropathy, who were randomized to placebo or 200 mg/day, 400 mg/day, or 600 mg/day lacosamide in a 1:1:1:1 ratio. Patients rated their pain twice-daily on the 11-point Likert scale.

Scores on the patient's global impression of pain showed that 81% of the 91 patients taking lacosamide 400 mg/day and 83% of patients taking lacosamide 600 mg/day said they were mildly, moderately or much better after taking the drug, Dr. Wymer said in his poster presentation on October 9^th. This level of improvement was reached by about 69% of patients on the 200 mg/day low dose of lacosamide and 69% of placebo patients.

The difference between the 91-patient 400 mg dose lacosamide group and the 93-patient placebo group reached significance at the P = .0162 level. The difference between the 93-patient 600 mg dose lacosamide group and the placebo patients reached statistical significance at the P = .0153 level.

Dr. Wymer reported that side effects were generally similar across all the groups, but the patients receiving the 600 mg dose had a few more events. There were 73 reported adverse events among those on placebo. That compared to 70 events of those on 200 mg of lacosamide; 71 events among those on the 400 mg lacosamide patients and 83 events among those taking 600 mg/day of lacosamide.

"No clinically relevant effect on electrocardiogram and laboratory parameters were identified," Dr. Wymer said, reported on behalf of the 56 investigators in the SP742 Study Group, which included researchers from Schwarz Pharma.

He noted that 8.6% of placebo patients; 7.5% of patients taking the 200 mg/day dose of lacosamide; 225 of those on 400 mg lacosamide and 39.8% of those taking the 400 mg lacosamide discontinued their study medication.

The presentation was sponsored by Schwarz Pharma, Monheim, Germany.


[Presentation title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Lacosamide in Painful Distal Diabetic Neuropathy. Abstract M-140]

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