Eslicarbazepine Acetate as Add-On Treatment to One Baseline Antiepileptic Drug (ESLADOBA) (NCT01532726) | Clinical Trial Compass
CompletedNot Applicable
Eslicarbazepine Acetate as Add-On Treatment to One Baseline Antiepileptic Drug (ESLADOBA)
Portugal56 participantsStarted 2012-03
Plain-language summary
This is a multicenter, non-interventional, prospective study. The observation period comprises at least 6 months, from the initiation of ESL add-on therapy in adult patients with partial-onset epilepsy not sufficiently controlled with one AED, until the first visit that occurs between 6 and 9 months of follow-up. The observation period will end after 9 months of follow-up even if the final assessment is not performed.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Male or female outpatient, 18 years or older;
* The patient has an established diagnosis of epilepsy and has experienced at least one partial-onset seizure, with or without secondary generalization, within four weeks prior to initiation of adjunctive ESL;
* The patient is not sufficiently controlled on a current antiepileptic monotherapy and, in the neurologist clinical judgment, it is in the patient's best interest to be prescribed with adjunctive ESL;
* The neurologist's decision to prescribe ESL has been made before and independently of his/her decision to include the patient in this study;
* The patient's treatment is in accordance with the SPC of ESL;
* Written informed consent from the patient (or legally acceptable representative, if the subject is unable to provide informed consent).
Exclusion Criteria:
* Known hypersensitivity to the active substance, carboxamide derivatives (e.g. oxcarbazepine or carbamazepine) or to any of its excipients;
* Patient with 2nd or 3rd degree atrioventricular block;
* Patient treated with an experimental drug within four weeks prior to the introduction of ESL;
* Female patient who is pregnant, lactating, or who is planning to become pregnant during the study period;
* Patient starting ESL outside the approved SPC at enrolment.