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NCT Number: NCT04421846

Study of Pathophysiology of Status Epilepticus and Dysimmune Encephalitis

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.

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Key information

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

Collection of biological samples and clinical/paraclinical data

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

Other

Collection of biological samples and clinical/paraclinical data

Primary outcomes

  1. 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

    Time frame: 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)

Secondary outcomes

  1. Identification of new dysimmune abnormalities

    Time frame: 9 months and 24 months

    Lymphocyte phenotyping, cytokines quantification

  2. Identification of specific EEG patterns associated to dysimmune encephalitis and/or status epilepticus

    Time frame: 9 months and 24 months

    EEG signals will be reviewed and classifiyed according to a EEG-based seizure build-up score in status epilepticus (EaSiBUSSEs)

  3. Identification of new genetic pathways associated to dysimmune encephalitis and status

    Time frame: 9 months and 24 months

    Genetic biomarkers

  4. Identification of new metabolic pathway that may participate in the excitotoxicity observed in status epilepticus or dysimmune encephalitis

    Time frame: 9 months and 24 months

    Looking for diagnostic and prognosis biomarkers. Characterization of the brain cholesterol homeostasis with UPLC-MS/MS method and enzymatic assays. Evaluation of new biomarkers (proteins, lipids, genes).

Study contacts

Contact information is provided by the study sponsor or research team.

Vincent NAVARRO, Pr

CONTACT

[email protected]

01 42 16 19 40

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

COLETTE : Study of the Pathophysiology of Status Epilepticus and Dysimmune Encephalitis and Identification of Valuable Biomarkers

Acronym: COLETTE

Important dates

Study start
2020
Primary completion
2033
Study completion
2033
First posted
Jun 9, 2020
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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