Clinical trial Recruiting at 1 site Interventional Ages 2 and up

Understanding the causes of severe epilepsy and autoimmune encephalitis

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

Run by Assistance Publique - Hôpitaux de Paris · NCT04421846 · Data updated 2026-11-12

This study is trying to understand what causes severe epilepsy and related brain inflammation by looking at samples from patients to find new ways to treat these conditions.

Quick facts

Study typeInterventional
Ages2 Years and up
SexAll
Enrollment400 (estimated)
SponsorAssistance Publique - Hôpitaux de Paris
Academic / other
Locations1 site (Paris)
StatusRecruiting
StartedNovember 25, 2020
Main results expectedJune 1, 2033
Study endsJune 1, 2033
Registry record updatedMay 22, 2026
Trial IDNCT04421846 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include patients aged 2 years or older with status epilepticus or epilepsy associated with dysimmune encephalitis.

Probably not a fit

Patients without status epilepticus or dysimmune encephalitis may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study collects blood, cerebrospinal fluid, and post-mortem tissues from patients with status epilepticus or epilepsy linked to dysimmune encephalitis, as well as control patients. The goal is to explore the pathophysiology of these severe epileptic disorders and identify new therapeutic strategies. By analyzing biological samples and clinical data, the study aims to uncover mechanisms that trigger epileptogenesis and the role of autoimmunity in these conditions.

Why it matters

Potential benefit: If successful, this study could lead to new treatments for patients suffering from severe epilepsy and related disorders.

How similar studies have gone: While the study explores novel aspects of epilepsy and autoimmunity, similar studies have shown promise in understanding related conditions.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Hôpital de la Pitié Salpêtrière
    Paris, France
    Recruiting

Study contacts

  • Principal investigator: Vincent NAVARRO, Pr — Hôpital Pitié Salpêtrière - Assitance Publique Hôpitaux de Paris
  • Study coordinator: Vincent NAVARRO, Pr
  • Email: vincent.navarro@aphp.fr
  • Phone: 01 42 16 19 40

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  • Ketamine added to levetiracetam to stop prolonged convulsive seizures

    This trial will test whether giving ketamine (two different doses) along with levetiracetam helps stop benzodiazepine-refractory status epilepticus in people age 1 and older.

    Recruiting at 36 sites Phase 3 University of Virginia · Birmingham, Alabama and 62 other locations · NCT06907173

  • Improving prognosis for patients with Status Epilepticus

    This study is trying to find blood markers that can help predict how well patients with Status Epilepticus will recover in the ICU and how their thinking skills may change after they leave the hospital.

    Recruiting London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · London, Ontario · NCT06590883

  • Using Rapid-Response EEG to Diagnose Seizures in Children

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    Recruiting Children's Hospital at Montefiore · The Bronx, New York · NCT06564662

  • Two-way video support for paramedics caring for infants with life-threatening breathing problems.

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.