Risk Factors of SUDEP (NCT03074279) | Clinical Trial Compass
UnknownNot Applicable
Risk Factors of SUDEP
France408 participantsStarted 2011-07-01
Plain-language summary
Numerous studies over the past decade have shown without any doubt that there is a higher mortality risk in patients with epilepsy than in the general population. The cause of death may be related to the cause of epilepsy, being directly related to a seizure (status epilepticus or sudden unexpected death in epilepsy; SUDEP), a consequence of seizures (accidents, etc), other associated pathologies (cancer, cardiovascular disease, ischemic heart disease, pneumonia, etc) or an associated disorder (depression or suicide). A SUDEP is defined as a sudden, non-traumatic, unexpected death in a patient with epilepsy, not necessarily in the presence of witnesses, that is not due to drowning, with or without evidence of a seizure, excluding documented status epilepticus and in which a post-mortem autopsy reveals no anatomical or toxicological cause of death. Little is known about SUDEP and its mechanisms and risk factors.
This epidemiological study is based on the RSME. The Main objective of this study to identify risk factors of SUDEP, in particular night-time supervision and the risks associated with anti-epileptic drugs including compliance and drug interactions.
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:
Cases : Any patient with active epilepsy (treated or not) or in remission under treatment or without treatment for at least two years who died as a result of confirmed or probable SUDEP or NEAR SUDEP during the study period.
Controls : Patient with active epilepsy (treated or not) or in remission under treatment or without treatment for at least two years and matched by: age, epileptic syndrom and level of seizure controls
Exclusion Criteria:
For cases and controls :patient not living in France, refusal of participation
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.
1Since this study is focused on identifying risk factors for SUDEP — sudden unexpected death in epilepsy — should I be concerned that my own risk of SUDEP is high enough that my doctor thinks I should be part of this kind of research?
2The recruitment status for this trial is listed as unknown, so how would my doctor find out whether this study is still actively enrolling participants and who I would need to contact to get current information?
3Because this trial is listed as 'Phase NA,' it seems to be an observational or data-collection study rather than a treatment trial — can my doctor explain what that means in practice, such as whether I'd be receiving any new treatment or just being monitored and interviewed?
4If I were to participate in a study like this, what kinds of information or data would likely be collected from me — for example, my seizure history, medication records, or sleep patterns — and how would that affect my privacy?
5Given that this study is about understanding risk factors rather than testing a new treatment, would my doctor recommend I also explore other options focused on better controlling my seizures, and how would participating in this study fit alongside my current epilepsy management plan?
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.