Understanding the causes of severe epilepsy and autoimmune encephalitis
COLETTE : Study of the Pathophysiology of Status Epilepticus and Dysimmune Encephalitis and Identification of Valuable Biomarkers
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 2 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT04421846 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients aged 2 years or older with status epilepticus or epilepsy associated with dysimmune encephalitis.
Not a fit: Patients without status epilepticus or dysimmune encephalitis may not benefit from this study.
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 performed: While the study explores novel aspects of epilepsy and autoimmunity, similar studies have shown promise in understanding related conditions.
Eligibility criteria
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 this trial is running
Paris
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.