Understanding the causes of severe epilepsy and autoimmune encephalitis
Official title: COLETTE : Study of the Pathophysiology of Status Epilepticus and Dysimmune Encephalitis and Identification of Valuable Biomarkers
Run by Assistance Publique - Hôpitaux de Paris · NCT04421846 · Data updated 2026-11-12
This study is trying to understand what causes severe epilepsy and related brain inflammation by looking at samples from patients to find new ways to treat these conditions.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 2 Years and up |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Status | Recruiting |
| Started | November 25, 2020 |
| Main results expected | June 1, 2033 |
| Study ends | June 1, 2033 |
| Registry record updated | May 22, 2026 |
| Trial ID | NCT04421846 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients aged 2 years or older with status epilepticus or epilepsy associated with dysimmune encephalitis.
✕Probably not a fit
Patients without status epilepticus or dysimmune encephalitis may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study collects blood, cerebrospinal fluid, and post-mortem tissues from patients with status epilepticus or epilepsy linked to dysimmune encephalitis, as well as control patients. The goal is to explore the pathophysiology of these severe epileptic disorders and identify new therapeutic strategies. By analyzing biological samples and clinical data, the study aims to uncover mechanisms that trigger epileptogenesis and the role of autoimmunity in these conditions.
Why it matters
Potential benefit: If successful, this study could lead to new treatments for patients suffering from severe epilepsy and related disorders.
How similar studies have gone: While the study explores novel aspects of epilepsy and autoimmunity, similar studies have shown promise in understanding related conditions.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Hôpital de la Pitié Salpêtrière
Paris, France Recruiting
Study contacts
- Principal investigator: Vincent NAVARRO, Pr — Hôpital Pitié Salpêtrière - Assitance Publique Hôpitaux de Paris
- Study coordinator: Vincent NAVARRO, Pr
- Email: vincent.navarro@aphp.fr
- Phone: 01 42 16 19 40
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.