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June 25, 2017

Bial and Eisai report positive results from Phase II trial of Zebinix for epilepsy

Bial and Eisai have reported a positive outcome from a Phase II clinical trial (Study 208) of Zebinix (eslicarbazepine acetate) in children with focal-onset epilepsy.

Bial and Eisai have reported a positive outcome from a Phase II clinical trial (Study 208) of Zebinix (eslicarbazepine acetate) in children with focal-onset epilepsy.

Eslicarbazepine acetate is a voltage-gated, sodium channel blocker currently being designed to selectively target the channel’s slow inactivated state.

The results showed no negative impact of Zebinix on neurocognitive functions such as attention, information processing and working memory of the subjects.

The randomised, two-part Study 208 trial investigated the effect of adjunctive eslicarbazepine acetate on power of attention in six to 16-year-old refractory focal onset epilepsy patients.

The double-blind, placebo-controlled first part of the trial included an observational period of four weeks, a double-blind period of 12 weeks and tapering-off periods.

"The results showed no negative impact of Zebinix on neurocognitive functions such as attention, information processing and working memory of the subjects."

The one-year, uncontrolled, open-label second part involved the administration of 10mg/kg a day of eslicarbazepine acetate, with an option to titrate up to 30mg/kg a day depending on the clinical response.

At the end of the first part of the trial, the drug candidate did not show a statistically significant difference in the case of secondary endpoints such as continuity of attention, quality of working memory and speed of memory.

In Europe, eslicarbazepine acetate is indicated as an adjunctive therapy in adults, adolescents and children older than six with partial-onset seizures, and as monotherapy to treat adults with partial-onset seizures with or without secondary generalisation.

The drug candidate’s efficacy was previously validated in a proof-of-concept Phase II trial and three Phase III trials in 1,049 refractory partial onset seizure patients.

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