Epilepsy is the most common serious disease of the nervous system, affecting more than 70 million people worldwide. Recently, a number of new treatments have become available for epilepsy patients, with a number of additional treatments currently being developed. When treatments are being trialled during the development phase, it is unclear whether any benefits which are seen during this phase will also be seen once the treatment is made available to epilepsy patients in the general population. A key reason for this is that epilepsy patients who are given a treatment during the trial and development phase can be different to epilepsy patients who are in the general population. An example of the types of differences include differences in age, differences in other medications which patients may be taking, and differences in other diseases which patients may have alongside epilepsy. These differences can mean that a treatment which was shown to be beneficial during the development phase, is not as beneficial once it is used in epilepsy patients in the general population. In this study, we compare the differences between epilepsy patients who were part of a recent development trial for a new epilepsy treatment, and epilepsy patients in the general population, to see what differences exist between them.
This is an exploratory study to assess the generalizability of findings of the SP0993 clinical trial comparing lacosamide with carbamazepine for the treatment of newly diagnosed focal epilepsy. The specific aims of the study are:
1. To compare characteristics of patients enrolled in the SP0993 trial with those of epilepsy patients newly diagnosed with focal epilepsy (i.e. partial-onset seizures, POS) in routine clinical practice in the UK; and
2. To estimate the proportion of newly diagnosed epilepsy patients treated in routine clinical practice that would have been eligible for SP0993 trial enrolment.
The study will be undertaken utilizing linked data within the Clinical Practice Research Database and Hospital Episode Statistics database. The study time frame will be 1 April 2011 to the most recent data available. Aim 1 will be evaluated by comparing patient characteristics (age, gender, time since diagnosis, comorbidities, and concomitant medications) between real-world newly diagnosed epilepsy patients treated with lacosamide or carbamazepine and the respective patients from the SP0993 trial. Aim 2 will be assessed by applying each exclusion criteria from the SP0993 trial to the patient population in our study meeting the SP0993 inclusion criteria (i.e. newly diagnosed POS patients initiating lacosamide or carbamazepine). The number and proportion of patients meeting each exclusion criteria as well as the number and percentage of patients remaining after application of all inclusion criteria will be reported.
Jessica Jalbert - Chief Investigator - Regeneron Pharmaceuticals, Inc.
Jessica Jalbert - Corresponding Applicant - Regeneron Pharmaceuticals, Inc.
Aastha Chandak - Collaborator - LA-SER Europe Ltd ( UK )
Simon Borghs - Collaborator - UCB Pharma SA - UK
HES Admitted Patient Care;HES Outpatient