Status EpilepticusCOLETTENCT04421846
Study of Pathophysiology of Status Epilepticus and Dysimmune Encephalitis
A study testing Blood sampling, cerebrospinal fluid , post-mortem cerebral tissues (NA for the Group 3) and Blood sampling, cerebrospinal fluid, stool sampling post-mortem cerebral tissues (NA for the Group 3) in people with Status Epilepticus and Dysimmune Encephalopathy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Status Epilepticus, Dysimmune Encephalopathy
- What is being tested?
- Blood sampling, cerebrospinal fluid , post-mortem cerebral tissues (NA for the Group 3) and Blood sampling, cerebrospinal fluid, stool sampling post-mortem cerebral tissues (NA for the Group 3)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 25 Nov 2020to 1 Jun 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital de la Pitié Salpêtrière
Paris, 75013
Vincent NAVARRO, Pr, 01 42 16 19 40, vincent.navarro@aphp.fr
Aurélie HANIN, Dr, aurelie.hanin@icm-institute.org
About this study
Official title: COLETTE : Study of the Pathophysiology of Status Epilepticus and Dysimmune Encephalitis and Identification of Valuable Biomarkers
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.
Read the 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.
- Conditions
- Status Epilepticus, Dysimmune Encephalopathy
- Being tested
- 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)
- Keywords
- Epilepsy, Status Epilepticus, Autoimmunity
- Medical subject headings
- Status Epilepticus, Epilepsy, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Group 1 : Status epilepticus | Other | Not described Receives: Other: Blood sampling, cerebrospinal fluid, stool sampling post-mortem cerebral tissues (NA for the Group 3) |
| Group 2 : Dysimmune encephalitis | Other | Not described Receives: Other: Blood sampling, cerebrospinal fluid , post-mortem cerebral tissues (NA for the Group 3) |
| Group 3 : Control patients | Other | Not described Receives: Other: Blood sampling, cerebrospinal fluid , post-mortem cerebral tissues (NA for the Group 3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 9 months and 24 months
Secondary outcomes (4)
Identification of new dysimmune abnormalities
Lymphocyte phenotyping, cytokines quantification
Measured: 9 months and 24 months
Identification of specific EEG patterns associated to dysimmune encephalitis and/or status epilepticus
EEG signals will be reviewed and classifiyed according to a EEG-based seizure build-up score in status epilepticus (EaSiBUSSEs)
Measured: 9 months and 24 months
Identification of new genetic pathways associated to dysimmune encephalitis and status
Genetic biomarkers
Measured: 9 months and 24 months
Identification of new metabolic pathway that may participate in the excitotoxicity observed in status epilepticus or dysimmune encephalitis
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).
Measured: 9 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start25 Nov 2020
- Primary completion1 Jun 2033 (estimated)
- Study completion1 Jun 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Status EpilepticusStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent NAVARRO, Pr, Principal investigator, Hôpital Pitié Salpêtrière - Assitance Publique Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421846
- Sponsor's protocol ID
- APHP200306
- Other IDs
- 2020-A00053-36
- Acronym
- COLETTE
- Status last verified
- May 2026
- First submitted
- 4 Jun 2020
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COLETTE : Study of the Pathophysiology of Status Epilepticus and Dysimmune Encephalitis and Identification of Valuable Biomarkers
- ClinicalTrials.gov ID
- NCT04421846
- Acronym / sponsor ID
- COLETTE / APHP200306
- Conditions
- Status Epilepticus, Dysimmune Encephalopathy
- Keywords
- Epilepsy, Status Epilepticus, Autoimmunity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- 1 Jun 2033 (estimated)
- Study completion
- 1 Jun 2033 (estimated)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- 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
- Patients aged 2 years or above, with clinical signs of epilepsy associated to dysimmune encephalitis.
Key exclusion criteria (13 listed)
- Women with known or clinically detected pregnancy.
- Patient deprived of liberty
- Patients with known neurodegenerative disease.
- Women with known or clinically detected pregnancy.
- Patient deprived of liberty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampling, cerebrospinal fluid , post-mortem cerebral tissues (NA for the Group 3)Collection of biological samples and clinical/paraclinical data | Other | Group 2 : Dysimmune encephalitis, Group 3 : Control patients |
| Blood sampling, cerebrospinal fluid, stool sampling post-mortem cerebral tissues (NA for the Group 3)Collection of biological samples and clinical/paraclinical data | Other | Group 1 : Status epilepticus |
Primary outcome
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)
4 secondary outcomes
Identification of new dysimmune abnormalities
Time frame: 9 months and 24 months
Identification of specific EEG patterns associated to dysimmune encephalitis and/or status epilepticus
Time frame: 9 months and 24 months
Identification of new genetic pathways associated to dysimmune encephalitis and status
Time frame: 9 months and 24 months
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vincent NAVARRO, Pr principal investigator
Hôpital Pitié Salpêtrière - Assitance Publique Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling, cerebrospinal fluid , post-mortem cerebral tissues (NA for the Group 3) and Blood sampling, cerebrospinal fluid, stool sampling post-mortem cerebral tissues (NA for the Group 3) in people with Status Epilepticus and Dysimmune Encephalopathy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vincent NAVARRO, Pr (01 42 16 19 40, vincent.navarro@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.