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DESIGN OF THE EPOS STUDY: AN OPEN-LABEL, MULTICENTRE, NON-INTERVENTIONAL STUDY TO EVALUATE ESLICARBAZEPINE ACETATE AS ADJUNCTIVE TREATMENT TO ONE BASELINE ANTIEPILEPTIC DRUG IN ADULTS WITH PARTIAL-ONSET SEIZURES
  1. M Holtkamp,
  2. C Lawthom,
  3. I Chouette
  1. Charité–Universitätsmedizin Berlin; Aneurin Bevan Health Board, Gwent; Eisai Ltd, Hatfield

    Abstract

    Purpose Eslicarbazepine acetate (ESL) is a once-daily voltage-gated sodium channel blocker that was approved in Europe in 2009 as adjunctive therapy in adults with partial-onset seizures, with or without secondary generalisation, based on an initial proof-of-concept Phase II trial and three subsequent Phase III trials. This non-interventional study aims to increase the knowledge about ESL's effectiveness and tolerability in routine clinical practice, when used to treat adult epilepsy patients who are less refractory than those included in Phase III adjunctive clinical trials.

    Method The Eslicarbazepine acetate in Partial-Onset Seizures study (EPOS) is a prospective, multicentre, open-label, non-interventional study involving adults with partial-onset seizures insufficiently controlled with AED monotherapy, for whom the treating physician has previously decided it was in the patient's best interest to be initiated adjunctive ESL, according to its license and Summary of Product Characteristics. Patients will be seen at baseline and then according to normal clinical practice, over a follow-up period of 6−7 months. Study assessments will be conducted at baseline and after 3 and 6 months. Primary endpoint will be 6-month retention rate. Other assessments will include seizure frequency, adverse events and quality of life.

    Results EPOS is expected to enrol approximately 800 patients from ≥200 centres in Denmark, France, Germany, Norway, Sweden and UK. Recruitment is expected to commence March 2012 and the study is expected to complete end of 2013.

    Conclusion EPOS will provide a better understanding of the use of ESL as early adjunctive therapy in a clinical practice setting.

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