Study of Pathophysiology of Status Epilepticus and Dysimmune Encephalitis (NCT04421846) | Clinical Trial Compass
RecruitingNot Applicable
Study of Pathophysiology of Status Epilepticus and Dysimmune Encephalitis
France400 participantsStarted 2020-11-25
Plain-language summary
COLETTE is an interventional study for which blood, cerebrospinal fluid and post-mortem tissues are collected in patients with status epilepticus or epilepsy associated to dysimmune encephalitis as well as in control patients, to better understand the pathophysiology of these severe epileptic disorders.
Who can participate
Age range
2 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:
Group 1:
* Patients aged 2 years or above, with status epilepticus.
* Affiliation to a French social security system excluding "Aide Médicale" Etat (AME).
* Patients or relatives have been informed and given free informed and written consent to participate
* Patients under legal protection (guardianship, curatorship) or not
Group 2:
* Patients aged 2 years or above, with clinical signs of epilepsy associated to dysimmune encephalitis.
* Affiliation to a French social security system excluding "Aide Médicale" Etat (AME).
* Patients or relatives have been informed and given free informed and written consent to participate
* Patients under legal protection (guardianship, curatorship) or not
Group 3:
* Patients aged 18 years or above, without status epilepticus and/or dysimmune encephalitis.
* Affiliation to a French social security system excluding "Aide Médicale" Etat (AME).
* Patients or relatives have been informed and given free informed and written consent to participate
* Patients under legal protection (guardianship, curatorship) or not
Exclusion Criteria:
Group 1:
* Women with known or clinically detected pregnancy.
* Patient deprived of liberty
* Patients with known neurodegenerative disease.
Group 2:
* Women with known or clinically detected pregnancy.
* Patient deprived of liberty
* Patients have been already treated by corticoids or IgIV.
Group 3:
* Women with known or clinically detected pregnancy.
* Patient deprived of liberty.
* Pa…
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.
What they're measuring
1
Identification of (i) antibodies in the plasma and in the cerebrospinal fluid of patients with dysimmune encephalitis and (ii) biomarkers for neuronal death in the plasma and in the cerebrospinal fluid of patients with status epilepticus