NCT04421846 Study of Pathophysiology of Status Epilepticus and Dysimmune Encephalitis
| NCT ID | NCT04421846 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Status Epilepticus |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2020-11-25 |
| Primary Completion | 2033-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2020-11-25 with a primary completion date of 2033-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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. * Patients with status epilepticus. * Patients with known neurodegenerative disease, brain tumor, severe head trauma, meningitis, subarachnoid hemorrhages, stroke.
Contact & Investigator
Vincent NAVARRO, Pr
PRINCIPAL INVESTIGATOR
Hôpital Pitié Salpêtrière - Assitance Publique Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT04421846 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, studying Status Epilepticus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04421846 currently recruiting?
Yes, NCT04421846 is actively recruiting participants. Contact the research team at vincent.navarro@aphp.fr for enrollment information.
Where is the NCT04421846 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT04421846 clinical trial?
NCT04421846 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Vincent NAVARRO, Pr at Hôpital Pitié Salpêtrière - Assitance Publique Hôpitaux de Paris. The trial plans to enroll 400 participants.