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Lacosamide Decreases Seizure Frequency in Epileptic Patients: Presented at ANA

By Crina Frincu-Mallos, PhD

BALTIMORE, Md -- October 14, 2009 -- Lacosamide induced significant reductions in seizure frequency of up to 42% in epileptic patients with complex partial seizures and 86% in those with a mixture of simple and complex seizures, according to a study presented here at the American Neurological Association (ANA) 134th Annual Meeting.

Lacosamide is a new antiepileptic drug that recently received US Food and Drug Administration approval as adjuvant therapy for the treatment of partial-onset seizures in adults, said Jouko Isojarvi, MD, PhD, Schwarz Biosciences (member of the UCB-Group), Research Triangle Park, Raleigh, North Carolina, on October 12.

"Partial-onset seizures are the most frequent epileptic seizures," explained Dr. Isojarvi. They can be categorised as simple, complex, or partial with secondary generalisation (a mix of simple and complex), depending on whether consciousness is impaired.

"The clinical development program for lacosamide included 3 multicentre, randomised, double-blind, placebo-controlled, fixed-dose efficacy trials," said Dr. Isojarvi.

The researchers performed an exploratory analysis of the data from these phase 2/3 trials. They assessed changes in seizure frequency, with a focus on the epileptic patients who experienced >50% reduction in seizure frequency.

A total of 1,294 patients were randomised to placebo or lacosamide 200, 400, or 600 mg/day in this retrospective analysis.

"The use of concomitant antiepileptics was similar among treatment groups," noted Dr. Isojarvi, with carbamazepine, lamotrigine, levetiracetam, valproic acid, and topiramate being the most common.

"The largest reductions in seizure frequency over placebo in the lacosamide treatment groups were seen for complex partial seizures and partial seizures with secondary generalisation," said Dr. Isojarvi.

For patients with complex seizures, the reduction in seizure frequency per 28 days was 34.1% in the 200-mg group, 40.8% in the 400-mg group, and 41.9% in the 600-mg group, versus 22.4% with placebo. Similarly, for patients with partial seizures with secondary generalisation, the reduction in seizure frequency per 28 days was 50.0%, 55.6%, and 85.9% in the 200-, 400-, and 600-mg/day groups, respectively, versus 32.5% with placebo. In contrast, reductions in seizure frequency found in patients with simple partial-onset seizures were similar to placebo.

In terms of response to lacosamide treatment resulting in >=50% change from baseline, up to 43% of patients with complex partial seizures (vs 29% placebo) and 65% of those with partial seizures with secondary generalisation (vs 37% placebo) were classified as responders.

Funding for this study was provided by UCB, Inc.

[Presentation title: Lacosamide Efficacy in Partial-Onset Seizures With and Without Secondary Generalization: A Pooled Analysis of Three Phase II/III Trials. Abstract M-44]

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