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Clinical Trials in France / NCT04421846
Recruiting Not applicable

Study of Pathophysiology of Status Epilepticus and Dysimmune Encephalitis

NCT04421846 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Not applicable
Started
2020-11-25
Last updated
2026-05-22

Condition(s) studied

Status EpilepticusDysimmune Encephalopathy

Investigational drug(s) / intervention(s)

Blood sampling, cerebrospinal fluid , post-mortem cerebral tissues (NA for the Group 3)Blood sampling, cerebrospinal fluid, stool sampling post-mortem cerebral tissues (NA for the Group 3)

Blood sampling, cerebrospinal fluid , post-mortem cerebral tissues (NA for the Group 3): Collection of biological samples and clinical/paraclinical data

Blood sampling, cerebrospinal fluid, stool sampling post-mortem cerebral tissues (NA for the Group 3): Collection of biological samples and clinical/paraclinical data

Study 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

Sex
ALL
Min age
2 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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 — 9 months and 24 months
    Looking for antibodies with cell-based binding assay or monospecific recombinant assay. Identification of biomarkers for neuronal death with electrochemiluminometric sandwich immunoassays (Kryptor and ModularE170, Roche Diagnostic)

Trial sites (1)

FacilityCityRegionStatus
Hôpital de la Pitié Salpêtrière Paris France Recruiting

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Other trials for the same condition

Status Epilepticus in the Critically Ill Patients Recruiting
Targeted Hypothermia Versus Targeted Normothermia After Convulsive Refractory Status Epilepticus Starting soon
Patient-reported Outcome and Patient-reported Experience After Status Epilepticus Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04421846 on ClinicalTrials.gov ↗ ← All trials in France