HATFIELD, England, October 3, 2012 /PRNewswire/ --
Bial and Eisai today present information on new studies designed to increase the understanding of the use of Zebinix(R) (eslicarbazepine acetate), a once-daily adjunctive therapy for adults with partial-onset seizures, with or without secondary generalisation, at the 10th European Congress on Epileptology (ECE) in London.[1]
These new data will be important as the successful treatment of partial-onset seizures remains a challenge, and up to a third of people with epilepsy do not achieve freedom from seizures despite appropriate therapy with anti-epileptic drugs.[2]
Eslicarbazepine acetate in Partial-Onset Seizures study (EPOS)[3]
Launched in March 2012, the Eslicarbazepine acetate in Partial-Onset Seizures (EPOS) study design presented here aims to provide a better understanding of the use of eslicarbazepine acetate in a clinical practice setting. EPOS is a prospective, multicentre, open-label, non-interventional study of adults with partial-onset seizures insufficiently controlled by monotherapy anti-epileptic treatment. The goal is to recruit approximately 800 patients from over 200 centres in Denmark, France, Germany, Norway, Sweden and the UK. The study primary endpoint will be 6-month retention rate and other assessments will include seizure frequency, adverse events and quality of life.
"The significant number of people with epilepsy who fail to achieve seizure control necessitates the need for on-going investigations in real life settings, " commented Martin Holtkamp, EPOS Principal Investigator from the University Hospital Charite, Germany. "Our non-interventional study will increase our knowledge of eslicarbazepine acetates efficacy and tolerability in routine practice when used to treat adults who are less refractory than those included in standard Phase III adjunctive therapy clinical trials. This will be very valuable information."
Eslicarbazepine acetate is currently licenced as an adjunctive treatment for adults with partial-onset seizures, with or without secondary generalisations (where the seizure extensively affects a patients consciousness by spreading to both sides of the brain).[1] It is not yet known whether eslicarbazepine acetate will demonstrate efficacy and tolerability if used as a monotherapy and in newly diagnosed patients. To address this question, also presented today is the design of a Phase III, double-dummy, active controlled, multinational non-inferiority monotherapy trial of eslicarbazepine acetate versus controlled-release carbamazepine in adults with partial-onset seizures.[4]
This study will enrol newly diagnosed epilepsy patients greater than or equal to18 years of age with documented partial-onset seizures and randomise in a 1:1 ratio.
Paediatric patients sometimes require specific dosing regimens, and additional safety and tolerability evidence beyond that available for adult populations is required. Eslicarbazepine acetate, which does not have a paediatric licence, is currently under investigation in a paediatric patient population for adjunctive use in partial-onset seizures in Europe.[5] The study aims to assess the efficacy and safety of eslicarbazepine acetate as adjunctive therapy in 252 children and adolescents (2 - 18 years old).[5]
There are a further 16 posters presented within this congress, many of which examine the pharmacokinetic and pharmacodynamic information pertaining to eslicarbazepine acetate.
See the original post here:
New Studies on Zebinix® Presented at Leading European Epilepsy Congress