NCT04421846

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Nov 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
Nov 2020Jun 2027

First Submitted

Initial submission to the registry

June 4, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

November 25, 2020

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

February 4, 2025

Status Verified

January 1, 2025

Enrollment Period

6.5 years

First QC Date

June 4, 2020

Last Update Submit

January 31, 2025

Conditions

Status EpilepticusDysimmune Encephalopathy

Keywords

EpilepsyStatus EpilepticusAutoimmunity

Outcome Measures

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

    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

Secondary Outcomes (4)

  • Identification of new dysimmune abnormalities

    9 months

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

    9 months

  • Identification of new genetic pathways associated to dysimmune encephalitis and status

    9 months

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

    9 months

Study Arms (3)

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

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 encephalitisGroup 3 : Control patients
Blood sampling, cerebrospinal fluid, stool sampling post-mortem cerebral tissues (NA for the Group 3)OTHER

Collection of biological samples and clinical/paraclinical data

Group 1 : Status epilepticus

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital de la Pitié Salpêtrière

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Status EpilepticusEpilepsyAutoimmune Diseases

Interventions

Blood Specimen CollectionSodium

Condition Hierarchy (Ancestors)

SeizuresNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBrain DiseasesCentral Nervous System DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesMetals, AlkaliElementsInorganic ChemicalsMetals, LightMetals

Study Officials

  • Vincent NAVARRO, Pr

    Hôpital Pitié Salpêtrière - Assitance Publique Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent NAVARRO, Pr

CONTACT

01 42 16 19 40vincent.navarro@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2020

First Posted

June 9, 2020

Study Start

November 25, 2020

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

February 4, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, 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.

Locations

FR(1)