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Autoimmune Encephalitis With Anti-NMDA Receptor Antibodies Following Herpetic Encephalitis (NMDARE-HSE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04339127
Recruitment Status : Recruiting
First Posted : April 9, 2020
Last Update Posted : April 9, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief 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.

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.


Condition or disease Intervention/treatment
Autoimmune Encephalitis Anti NMDA Receptor Encephalitis Herpetic Encephalitis Other: Description and analysis

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Study Type : Observational
Estimated Enrollment : 12 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Study of 12 Cases of Autoimmune Encephalitis With Anti-NMDA Receptor Antibodies Following Herpetic Encephalitis and Review of the Literature
Actual Study Start Date : April 1, 2020
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : October 1, 2020


Group/Cohort Intervention/treatment
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.
Other: Description and analysis
Retrospective, non-interventional study, using clinical, biological, radiological and therapeutic data collected during the initial diagnosis and follow-up.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
12 patients diagnosed between January 2014 and January 2020
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria- No respect of inclusion criteria


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04339127


Contacts
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Contact: Jérôme Honnorat, PhD 04 72 35 78 06 jerome.honnorat@chu-lyon.fr
Contact: Géraldine PICARD 0472355842 geraldine.picard@chu-lyon.fr

Locations
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France
Hospice Civils de Lyon Recruiting
Bron, France, 69500,
Contact: JEROME HONNORAT, PhD    04 72 35 78 06    jejerome.honnorat@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Study Director: Jérôme Honnorat National Reference Center of autoimmune encephalitis
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04339127    
Other Study ID Numbers: NMDARE-HSE
First Posted: April 9, 2020    Key Record Dates
Last Update Posted: April 9, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Encephalitis, Herpes Simplex
Anti-N-Methyl-D-Aspartate Receptor Encephalitis
Encephalitis
Hashimoto Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Thyroiditis, Autoimmune
Thyroiditis
Thyroid Diseases
Endocrine System Diseases
Paraneoplastic Syndromes, Nervous System
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Paraneoplastic Syndromes
Neurodegenerative Diseases
Autoimmune Diseases of the Nervous System
Autoimmune Diseases
Immune System Diseases
Encephalitis, Viral
Central Nervous System Viral Diseases
Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Infectious Encephalitis
Central Nervous System Infections