BioCentury
ARTICLE | Clinical News

Aptiom eslicarbazepine acetate: Additional Phase III data

January 20, 2014 8:00 AM UTC

On the secondary endpoint of change from baseline in standardized seizure frequency during the 18-week, double-blind treatment period, eslicarbazepine led to a median reduction in seizure frequency of 30.9% in the 1,200 mg arm and 41.5% in the 1,600 mg arm of Study 093-045. The median reductions in Study 093-046 were 36.1% in the 1,200 mg arm and 47.5% in the 1,600 mg arm. In Study 093-045, 5 patients in the 1,200 mg arm and 9 patients in the 1,600 mg arm were seizure-free during the 10-week monotherapy period. Eight patients in the low-dose arm and 17 patients in the high-dose arm were seizure-free during the last 4 weeks of monotherapy. Additionally, 36.7% of patients in the low-dose arm and 39.8% of patients in the high-dose arm achieved a >=50% reduction in seizure frequency from baseline during the 18-week, double-blind treatment period. In Study 093-046, 4 patients in the 1,200 mg arm and 10 patients in the 1,600 mg arm were seizure-free during the 10-week monotherapy period. Nine patients in the low-dose arm and 17 patients in the high-dose arm were seizure-free during the last 4 weeks of monotherapy. Additionally, 35.2% of patients in the low-dose arm and 46% of patients in the high-dose arm achieved a >=50% reduction in seizure frequency from baseline during the 18-week, double-blind treatment period. Data were presented at the American Epilepsy Society meeting in Washington D.C.

The trials enrolled patients with >=4 partial-onset seizures in the 8 weeks prior to screening and no 4-week seizure-free period while taking 1 or 2 antiepileptic drugs. Each trial included an 18-week double-blind treatment period consisting of a 2-week period for titration of eslicarbazepine, a 6-week period for taper or conversion off antiepileptic drugs and a 10-week monotherapy treatment period with once-daily 1,200 or 1,600 mg eslicarbazepine. The North American Study 093-045 enrolled 193 patients and the international Study 093-046 enrolled 172 patients. ...