Studies blood and spinal fluid in status epilepticus and dysimmune encephalitis
Collects blood and spinal fluid samples from people with severe seizures or immune-related encephalitis.
Key facts
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Where
- Paris, FranceSee the site
- Trial code
- Registry title
- Study of Pathophysiology of Status Epilepticus and Dysimmune Encephalitis
- Status
- Recruiting
- People taking part
- 400 people, planned
- Started
- 25 Nov 2020
- Expected to end
- 1 Jun 2033
- Type of study
- Interventional, 3 groups
- Treatments 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)
- Record updated
- 22 May 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people with status epilepticus, people with epilepsy linked to autoimmune brain inflammation, and a control group without these conditions.
- Age
- Groups 1 and 2: 2 years or older. Group 3 (control): 18 years or older.
- Sex
- All sexes can join.
- Disease stage
- Group 1: status epilepticus. Group 2: clinical signs of epilepsy linked to dysimmune (autoimmune) encephalitis. Group 3: no status epilepticus and no dysimmune encephalitis.
- Earlier treatment
- Group 2: people already treated with corticoids or IgIV cannot join.
Main reasons for not taking part
- Pregnancy (known or clinically detected)
- Deprived of liberty
- Known neurodegenerative disease (Groups 1 and 3)
- Already treated with corticoids or IgIV (Group 2)
- Control group: status epilepticus, brain tumor, severe head trauma, meningitis, subarachnoid hemorrhage or stroke
The registry criteria, word for word
Show all 24 criteriaShow less
Who can take part
- 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
Who cannot take part
- Patients with known neurodegenerative disease; Group 2:
- Patients with known neurodegenerative disease, brain tumor, severe head trauma, meningitis, subarachnoid hemorrhages, stroke
- Group 1:
- Women with known or clinically detected pregnancy
- Patient deprived of liberty
- 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
Where in France
- Hôpital de la Pitié-SalpêtrièreParis, FranceContact: Vincent NAVARRO, PrTaking people
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- Group 1 : Status epilepticusOther group
Treatment: Blood sampling, cerebrospinal fluid, stool sampling post-mortem cerebral tissues (NA for the Group 3)
- Group 2 : Dysimmune encephalitisOther group
Treatment: Blood sampling, cerebrospinal fluid , post-mortem cerebral tissues (NA for the Group 3)
- Group 3 : Control patientsOther group
Treatment: Blood sampling, cerebrospinal fluid , post-mortem cerebral tissues (NA for the Group 3)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- COLETTE : Study of the Pathophysiology of Status Epilepticus and Dysimmune Encephalitis and Identification of Valuable Biomarkers
- Plain-language title
- Studies blood and spinal fluid in status epilepticus and dysimmune encephalitisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 22 May 2026