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Adjuvant Therapy Eslicarbazepine Acetate Reduces Seizure Frequency in Epileptic Patients: Presented at ANA

By Crina Frincu-Mallos, PhD

BALTIMORE, Md -- October 15, 2009 -- Eslicarbazepine acetate (ESL) can be safely administered to epileptic patients with partial-onset seizures refractory to common antiepilepsy drugs (AEDs), according to a study presented here at the American Neurological Association (ANA) 134th Annual Meeting.

The drug has proven to be most efficacious in reducing seizure frequency when given at daily doses of 800-1,200 mg, said Mark Versavel, MD, PhD, Clinical Research and Medical Affairs, Sepracor Inc., Marlborough, Massachusetts, on October 12.

The investigators aimed to evaluate the efficacy and safety of ESL used as adjuvant therapy in epileptic adults presenting with >=4 partial-onset seizures monthly, although they were taking up to 3 AEDs. Secondary study goals were to determine the median relative reduction in seizure frequency and the responder rate in this patient population.

This was a phase 3 randomised, double-blind, placebo-controlled study testing ESL in patients accrued at 46 centres in 13 countries. Of the 503 patients (aged 18-69 years; mean duration of epilepsy 23.9 years), 395 were randomised and treated in the double-blind treatment phase, and 325 completed the trial. Most of the patients were on 2 AEDs, including carbamazepine (60%), valproic acid (22%), and lamotrigine (21%).

Patients were randomised to receive ESL 400, 800, or 1,200 mg once daily or placebo for 14 weeks. Those in the 1,200-mg group received 800 mg of study drug during the first 2 weeks of study.

Patients in the 800- and 1,200-mg groups had significantly fewer seizures (P < .01 and P < .0001, respectively) than those in the placebo group. Median relative reduction in seizure frequency during the 12-week maintenance period was similar in the ESL 800- and 1,200-mg groups (33%), which was greater than in the 400-mg (21%) or placebo (5%) groups. Interestingly, the number of concomitantly taken AEDs did not seem to affect the responses of patients given ESL, according to Dr. Versavel.

At least 2% of patients reported dizziness, somnolence, headache, nausea, vomiting, diplopia, and abnormal coordination as adverse events. Most ESL-related toxicities were mild (38%) or moderate (44%) in intensity; however, 18% of all drug-related adverse events were severe, warned the investigators.

The dropout rates due to drug-related adverse events were 12.5%, 18.8%, and 26.5% in the 400-, 800-, and 1,200-mg groups, respectively. Three percent of patients on placebo discontinued treatment.

In the intent-to-treat population, the responder rate (defined as the proportion of patients with at least a 50% reduction in seizure frequency) increased with the dose of ESL -- from 18% in the placebo group to 20% at 400 mg, 32% at 800 mg (P < .01), and 35% at 1,200 mg (P < .001) of the study drug.

The investigators concluded that ESL given as adjuvant therapy is well tolerated and reduces seizure frequency.

Funding for this study was provided by Sepracor, Inc.

[Presentation title: Evaluation of Efficacy and Safety of Eslicarbazepine Acetate (ESL) as Add-On Treatment in Adults With Refractory Partial-Onset Seizures: BIA-2093-302 Study. Abstract M-45]

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