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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.