Autoimmune EncephalitisNMDARE-HSENCT04339127
Autoimmune Encephalitis With Anti-NMDA Receptor Antibodies Following Herpetic Encephalitis
An observational study of Autoimmune Encephalitis and Anti NMDA Receptor Encephalitis, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Herpes Simplex Virus encephalitis is the most common infectious encephalitis, with an estimated annual incidence of 1 / 250,000 to 1 / 500,000 in industrialized countries. Despite a widely used antiviral treatment, the prognosis remains poor with a mortality of 5 to 20% and a considerable morbidity rate. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Autoimmune Encephalitis, Anti NMDA Receptor Encephalitis, Herpetic Encephalitis
- What is being tested?
- Description and analysis
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2020to 1 Oct 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 12 patients diagnosed between January 2014 and January 2020
Who may be able to join
- Clinical autoimmune encephalitis with anti-NMDA antibodies and documented by CBA in the CSF
- After a herpetic encephalitis documented by a positive viral PCR for HSV in the CSF
- Without age limit
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hospice Civils de Lyon
Bron, 69500,
JEROME HONNORAT, PhD, 04 72 35 78 06, jejerome.honnorat@chu-lyon.fr
About this study
Official title: Study of 12 Cases of Autoimmune Encephalitis With Anti-NMDA Receptor Antibodies Following Herpetic Encephalitis and Review of the Literature
Herpes Simplex Virus encephalitis is the most common infectious encephalitis, with an estimated annual incidence of 1 / 250,000 to 1 / 500,000 in industrialized countries. Despite a widely used antiviral treatment, the prognosis remains poor with a mortality of 5 to 20% and a considerable morbidity rate.
One of the contributing factors of bad prognosis is the development of encephalitis mediated by autoantibodies, most often directed against NMDA receptors, in the weeks following viral encephalitis.
The description of this pathology is recent, the pathophysiology of this process remains poorly understood, and the management of these patients is not yet codified.
- Being tested
- Description and analysis
- Medical subject headings
- Autoimmune Diseases of the Nervous System, Anti-N-Methyl-D-Aspartate Receptor Encephalitis, Encephalitis, Herpes Simplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Description and analysisOther
Retrospective, non-interventional study, using clinical, biological, radiological and therapeutic data collected during the initial diagnosis and follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Cohort NMDARE-HSE | Patients developing clinical autoimmune encephalitis with anti-NMDA antibodies after a herpetic encephalitis, managed by the National Reference Center for Paraneoplastic Syndromes and Autoimmune Encephalitis at the Neurological Hospital of Bron. Receives: Other: Description and analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Details of clinical, biological, imaging, therapeutic characteristics and patient's evolution.
Retrospective collection of clinical, diagnostic and therapeutic data, evolution at 6 and 12 months.
Measured: at 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start1 Apr 2020
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune EncephalitisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jérôme Honnorat, Study director, National Reference Center of autoimmune encephalitis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04339127
- Sponsor's protocol ID
- NMDARE-HSE
- Acronym
- NMDARE-HSE
- Status last verified
- Apr 2020
- First submitted
- 6 Apr 2020
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of 12 Cases of Autoimmune Encephalitis With Anti-NMDA Receptor Antibodies Following Herpetic Encephalitis and Review of the Literature
- ClinicalTrials.gov ID
- NCT04339127
- Acronym / sponsor ID
- NMDARE-HSE / NMDARE-HSE
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 9 Apr 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.
Herpes Simplex Virus encephalitis is the most common infectious encephalitis, with an estimated annual incidence of 1 / 250,000 to 1 / 500,000 in industrialized countries. Despite a widely used antiviral treatment, the prognosis remains poor with a mortality of 5 to 20% and a considerable morbidity rate.
One of the contributing factors of bad prognosis is the development of encephalitis mediated by autoantibodies, most often directed against NMDA receptors, in the weeks following viral encephalitis.
The description of this pathology is recent, the pathophysiology of this process remains poorly understood, and the management of these patients is not yet codified.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort NMDARE-HSE | – | Other: Description and analysisPatients developing clinical autoimmune encephalitis with anti-NMDA antibodies after a herpetic encephalitis, managed by the National Reference Center for Paraneoplastic Syndromes and Autoimmune Encephalitis at the Neurological Hospital of Bron. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 12 patients diagnosed between January 2014 and January 2020
Key inclusion criteria (3 listed)
- Clinical autoimmune encephalitis with anti-NMDA antibodies and documented by CBA in the CSF
- After a herpetic encephalitis documented by a positive viral PCR for HSV in the CSF
- Without age limit
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Description and analysisRetrospective, non-interventional study, using clinical, biological, radiological and therapeutic data collected during the initial diagnosis and follow-up. | Other | Cohort NMDARE-HSE |
Primary outcome
Details of clinical, biological, imaging, therapeutic characteristics and patient's evolution.
Time frame: at 6 and 12 months
Retrospective collection of clinical, diagnostic and therapeutic data, evolution at 6 and 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Jérôme Honnorat study director
National Reference Center of autoimmune encephalitis
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 Autoimmune Encephalitis and Anti NMDA Receptor Encephalitis, run by Hospices Civils de Lyon 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 3 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 9 Apr 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jérôme Honnorat, PhD (04 72 35 78 06, jerome.honnorat@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Details of clinical, biological, imaging, therapeutic characteristics and patient's evolution. (time frame: at 6 and 12 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 9 Apr 2020.