Study of Pathophysiology of Status Epilepticus and Dysimmune Encephalitis

NCT ID: NCT04421846

Last Updated: 2025-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-25

Study Completion Date

2027-06-01

Brief Summary

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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.

Detailed Description

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Epilepsy is one of the most common neurological condition which concerns around 50 million people worldwide. Epilepsy is characterized by a lasting predisposition to generate seizures. Epilepsy can present as heterogenous set of clinical symptoms and is related to extremely varied etiologies. Some epilepsies are triggered by antineuronal autoantibodies and/or complicated by a status epilepticus. These conditions may induce brain atrophy, and severe neurological sequels.

The severity of these epilepsies requires significant efforts to (i) identify new therapeutic strategies able to control the evolution of dysimmune encephalitis and refractory status epilepticus, (ii) to identify their etiologies and (iii) to propose neuroprotective strategies.

Therefore, the investigators will organize a collection of biological samples (blood, cerebrospinal fluid, post-mortem brain tissues) and paraclinical data (electroencephalogram, evoked potential, CT, MRI) in patients with severe epilepsies, whether or not associated with autoantibodies, and/or evolving into status epilepticus.

This study should bring new insights allowing to better understand mechanisms that trigger the emergence of an epileptic brain (epileptogenesis) through :

(i) the identification and characterization of new pathophysiological pathways involving autoimmunity directed against the cerebral cortex and associated with severe epilepsy (ii) the identification and characterization of pathophysiological pathways participating in the excitotoxicity observed in status epilepticus.

Conditions

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Status Epilepticus Dysimmune Encephalopathy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Group 1 : Status epilepticus

Group Type OTHER

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

Intervention Type OTHER

Collection of biological samples and clinical/paraclinical data

Group 2 : Dysimmune encephalitis

Group Type OTHER

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

Intervention Type OTHER

Collection of biological samples and clinical/paraclinical data

Group 3 : Control patients

Group Type OTHER

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

Intervention Type OTHER

Collection of biological samples and clinical/paraclinical data

Interventions

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

Collection of biological samples and clinical/paraclinical data

Intervention Type OTHER

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

Collection of biological samples and clinical/paraclinical data

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vincent NAVARRO, Pr

Role: PRINCIPAL_INVESTIGATOR

Hôpital Pitié Salpêtrière - Assitance Publique Hôpitaux de Paris

Locations

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Hôpital de la Pitié Salpêtrière

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Vincent NAVARRO, Pr

Role: CONTACT

01 42 16 19 40

Facility Contacts

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Vincent NAVARRO, Pr

Role: primary

01 42 16 19 40

Aurélie HANIN, Dr

Role: backup

Other Identifiers

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2020-A00053-36

Identifier Type: OTHER

Identifier Source: secondary_id

APHP200306

Identifier Type: -

Identifier Source: org_study_id

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