Study of Pathophysiology of Status Epilepticus and Dysimm... | NCT04421846

Studies
Study of Pathophysiology of Status Epilepticus and Dysimmune Encephalitis

NCT04421846

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Recruiting

Last Update Posted

May 22, 2026Actual

Enrollment

400Estimated

Phase

Not Applicable

Conditions

Status Epilepticus
Dysimmune Encephalopathy

Interventions

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)

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2020-A00053-36	Other Identifier	ANSM

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 25, 2020Actual

Primary Completion Date

Jun 1, 2033Estimated

Completion Date

Jun 1, 2033Estimated

First Submitted Date

Jun 4, 2020

First Submission Date that Met QC Criteria

Jun 4, 2020

First Posted Date

Jun 9, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 19, 2026

Last Update Posted Date

May 22, 2026Actual

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Group 1 : Status epilepticus	Other	Other: Blood sampling, cerebrospinal fluid, stool sampling post-mortem cerebral tissues (NA for the Group 3)
Group 2 : Dysimmune encephalitis	Other	Other: Blood sampling, cerebrospinal fluid , post-mortem cerebral tissues (NA for the Group 3)
Group 3 : Control patients	Other	Other: Blood sampling, cerebrospinal fluid , post-mortem cerebral tissues (NA for the Group 3)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood sampling, cerebrospinal fluid , post-mortem cerebral tissues (NA for the Group 3)	Other	Collection of biological samples and clinical/paraclinical data	Group 2 : Dysimmune encephalitis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	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)	9 months and 24 months

Secondary Outcomes

Measure	Description	Time Frame
Identification of new dysimmune abnormalities	Lymphocyte phenotyping, cytokines quantification	9 months and 24 months
Identification of specific EEG patterns associated to dysimmune encephalitis and/or status epilepticus

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Vincent NAVARRO, Pr	Contact	01 42 16 19 40		vincent.navarro@aphp.fr

Name	Affiliation	Role
Vincent NAVARRO, Pr	Hôpital Pitié Salpêtrière - Assitance Publique Hôpitaux de Paris	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital de la Pitié Salpêtrière	Recruiting	Paris		75013	France

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

Time Frame

Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor

Access Criteria

Researchers who provide a methodologically sound proposal.

URL

Not provided

ID	Term
D013226	Status Epilepticus
D004827	Epilepsy
D001327	Autoimmune Diseases

ID	Term
D012640	Seizures
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D007154	Immune System Diseases

ID	Term
D001800	Blood Specimen Collection
D012964	Sodium

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D011677	Punctures
D013514	Surgical Procedures, Operative
D008919	Investigative Techniques
D008672	Metals, Alkali
D004602	Elements
D007287	Inorganic Chemicals
D019565	Metals, Light
D008670	Metals