Is Protein S100B a Predictor of First-to-chronic Seizure Conversion in Adults? (NCT02424123) | Clinical Trial Compass
TerminatedNot Applicable
Is Protein S100B a Predictor of First-to-chronic Seizure Conversion in Adults?
Stopped: recruitment shortage
France37 participantsStarted 2016-10-11
Plain-language summary
Seizures represent an important clinical problem, accounting for at least 40% of adult onset epilepsy. Predicting seizure recurrence in subjects experiencing a first seizure is difficult due to the lack of prognostic biomarkers. Recent evidence has indicated that blood-brain barrier (BBB) dysfunction constitutes an etiological factor to seizures. In particular, it has been shown that modification of BBB permeability is associated with seizure activity. In addition, it was demonstrated that BBB permeability can be assessed by measuring serum level of the protein S100B. Based on these data and considerations the investigators will test whether the extent of BBB damage at time of first seizure is predictive for seizure recurrence.
The main objective of this study is to evaluate the association between the absolute (ng/ml) serum S100B levels (measured at time of the first seizure) and the experience, or not, of seizure recurrence within one year of follow-up.
Who can participate
Age range
18 Years – 59 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:
* The patient has been correctly informed.
* The patient must have given his informed and signed consent.
* The patient must be insured or beneficiary of a health insurance plan.
* The patient is at least (≥) 18 years old and less than (\<) 60 years old.
* The patient has experienced a first generalized, epileptic seizure (patients with partial onset and secondary generalization can also be included).
* The seizure has occurred less than 24 hours ago.
Exclusion Criteria:
* The patient is participating in another study that may interfere with the results or conclusions of this study.
* Within the past three months, the patient has participated in another study that may interfere with the results or conclusions of this study.
* The patient is in an exclusion period determined by a previous study.
* The patient is under judicial protection.
* The patient refuses to sign the consent.
* It is impossible to correctly inform the patient.
* The patient is pregnant or breast-feeding (MRI contraindicated).
* Patient has a previous abnormal brain imaging (MRI).
* Patient has abnormal biological tests for toxicology (alcohol, cocaine and cannabis tests), blood ionogram (hyponatremia \<130mM), liver enzymes (\>5N), inflammatory syndrome (elevated C-reactive protein).
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.