Acute Autoimmune EncephalitisEncephalitisNCT05605223
Study of Acute Autoimmune Encephalitis With Positive Antibodies in Eastern France
An observational study of Acute Autoimmune Encephalitis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The number of acute encephalitides diagnosed each year is gradually increasing, reaching approximately 5 to 10/100,000 per year; more than 50% of etiologies currently remain unknown. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Acute Autoimmune Encephalitis
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jun 2019to 26 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Minor subject (≤17 years) diagnosed between 01/01/2006 and 31/12/2018 with autoimmune encephalitis
Who may be able to join
- Age between 0 and 17 years at diagnosis
- Patient diagnosed between 01/01/2006 and 31/12/2018 with autoimmune encephalitis in one of the participating university hospitals (Besançon, Nancy, Strasbourg, Reims and Dijon)
- Presence of clinical criteria of clinical and/or radiographic encephalitis
- Presence of one or more antibodies in the blood or CSF
- Parental authority holders and their child of childbearing age having given their consent for the use of the child's data for this research
Who cannot join
- Refusal to participate in the study
- Absence of consultation at any of the study centers
- Absence of clinical and/or radiographic criteria for encephalitis.
- Absence of antibodies found in blood or CSF
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Pédiatrie 1 - CHU de Strasbourg - France
Strasbourg, 67091
About this study
Official title: Study of Acute Autoimmune Encephalitis With Positive Antibodies in Eastern France Between 2006 and 2018
The number of acute encephalitides diagnosed each year is gradually increasing, reaching approximately 5 to 10/100,000 per year; more than 50% of etiologies currently remain unknown. The majority of them are acute encephalitis of infectious origin, but it is estimated that 20% of encephalitis in northern Europe is related to an autoimmune mechanism with the majority of encephalitis with anti-NMDA Ac discovered recently in 2007. The study of a large American encephalitis cohort showed a death rate of 3% to 7% in cases of autoimmune encephalitis. Furthermore, delay in the initiation of effective treatment (tumor removal or immunotherapy) beyond 4 weeks is associated with a poor prognosis at 1 year.
It is therefore necessary to better understand the signs of autoimmune encephalitis in order to recognize the disease quickly and to start a treatment quickly; in order to improve the management and the prognosis of these children.
- Conditions
- Acute Autoimmune Encephalitis
- Keywords
- Acute autoimmune encephalitis, encephalitis, autoimmune encephalitis
- Medical subject headings
- Encephalitis, Autoimmune Diseases of the Nervous System
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective description of autoimmune encephalitis in children
Measured: Files analysed retrospectively from January 01, 2006 to December 31, 2018 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start26 Jun 2019
- Primary completion26 Oct 2019
- Study completion26 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Autoimmune EncephalitisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05605223
- Sponsor's protocol ID
- 7415
- Acronym
- Encephalitis
- Status last verified
- Dec 2023
- First submitted
- 28 Oct 2022
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Acute Autoimmune Encephalitis With Positive Antibodies in Eastern France Between 2006 and 2018
- ClinicalTrials.gov ID
- NCT05605223
- Acronym / sponsor ID
- Encephalitis / 7415
- Conditions
- Acute Autoimmune Encephalitis
- Keywords
- Acute autoimmune encephalitis, encephalitis, autoimmune encephalitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 26 Jun 2019 (actual)
- Primary completion
- 26 Oct 2019 (actual)
- Study completion
- 26 Dec 2019 (actual)
- First posted
- 4 Nov 2022 (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.
The number of acute encephalitides diagnosed each year is gradually increasing, reaching approximately 5 to 10/100,000 per year; more than 50% of etiologies currently remain unknown. The majority of them are acute encephalitis of infectious origin, but it is estimated that 20% of encephalitis in northern Europe is related to an autoimmune mechanism with the majority of encephalitis with anti-NMDA Ac discovered recently in 2007. The study of a large American encephalitis cohort showed a death rate of 3% to 7% in cases of autoimmune encephalitis. Furthermore, delay in the initiation of effective treatment (tumor removal or immunotherapy) beyond 4 weeks is associated with a poor prognosis at 1 year.
It is therefore necessary to better understand the signs of autoimmune encephalitis in order to recognize the disease quickly and to start a treatment quickly; in order to improve the management and the prognosis of these children.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Minor subject (≤17 years) diagnosed between 01/01/2006 and 31/12/2018 with autoimmune encephalitis
Key inclusion criteria (5 listed)
- Age between 0 and 17 years at diagnosis
- Patient diagnosed between 01/01/2006 and 31/12/2018 with autoimmune encephalitis in one of the participating university hospitals (Besançon, Nancy, Strasbourg, Reims and Dijon)
- Presence of clinical criteria of clinical and/or radiographic encephalitis
- Presence of one or more antibodies in the blood or CSF
- Parental authority holders and their child of childbearing age having given their consent for the use of the child's data for this research
Key exclusion criteria (4 listed)
- Refusal to participate in the study
- Absence of consultation at any of the study centers
- Absence of clinical and/or radiographic criteria for encephalitis.
- Absence of antibodies found in blood or CSF
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retrospective description of autoimmune encephalitis in children
Time frame: Files analysed retrospectively from January 01, 2006 to December 31, 2018 will be examined
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Autoimmune Encephalitis, run by University Hospital, Strasbourg, France 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 14 Dec 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective description of autoimmune encephalitis in children (time frame: Files analysed retrospectively from January 01, 2006 to December 31, 2018 will be examined). 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 14 Dec 2023.