By Crina Frincu-Mallos, PhD
BALTIMORE, Md -- October 16, 2009 -- When administered at efficacious doses to epileptic patients with partial-onset seizures refractory to common antiepilepsy drugs (AEDs), eslicarbazepine acetate (ESL) significantly improves the patients' quality of life (QOL) and depression symptoms, according to data presented here at the American Neurological Association (ANA) 134th Annual Meeting.
Jacqueline Zummo, Sepracor Inc., Marlborough, Massachusetts, presented data on October 12 from the 1-year, open-label extension of a randomised, multicentre, double-blind, placebo-controlled, phase 3 study testing ESL in epileptic patients.
The investigators aimed to evaluate the QOL and the symptoms of depression during long-term treatment with ESL, given as adjuvant therapy in patients with refractory partial-onset epilepsy.
Patients were randomised to receive either placebo (n = 100) or ESL once daily at the 400 mg (n = 96), 800 mg (n = 101), or 1,200 mg (n = 98) for a total duration of 14 weeks, with continued follow-up during the 1-year extension phase. The drug has proven to be most efficacious in reducing seizure frequency when given at daily doses of 800 mg (and up to 1,200 mg), the investigators noted.
All patients on trial were evaluated using the Quality-of-Life in Epilepsy Inventory-31 (QOLIE-31) and the Montgomery-Asberg Depression Rating Scale (MADRS) at baseline (prior to randomisation) and at the end of the open-label treatment.
Overall, the mean QOL score improved by 3.6 points -- a statistically significant change from the 60.2 points at baseline (P < .001). Among the items evaluated using the QOLIE-31 scale, there were significant improvements in patients' seizure anxiety (P < .0001), medication effects (P < .05), and overall score (P < .05).
Furthermore, the mean MADRS total score, which was 7.9 points at baseline, improved by -1.7 points, reaching statistical significance (P < .0001). Among the domains evaluated using the MADRS score, statistically significant improvement was reported in apparent sadness, reduced sleep, and pessimistic thoughts (all with P < .001).
In this open-label extension of the phase 3 study, ESL demonstrated statistically significant improvements from baseline in both QOL and depressive symptoms, concluded the investigators.
Funding for this study was provided by BIAL-Portela & CA S.A and Sepracor, Inc.
[Presentation title: Assessment of Quality-of-Life and Depressive Symptoms During Long-Term Treatment With Eslicarbazepine Acetate: BIA-2093-302 Study. Abstract M-46]
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