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

• Sponsor: Hospices Civils de Lyon (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04339127
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Anticipated Duration (Months): 6
• Patients Per Site Per Month: 2

Study Details

Study Description

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	Phase
Autoimmune Encephalitis; Anti NMDA Receptor Encephalitis; Herpetic Encephalitis	Other: Description and analysis

Study Design

• Study Type: Observational
• Anticipated 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: Apr 1, 2020
• Anticipated Primary Completion Date: Jun 1, 2020
• Anticipated Study Completion Date: Oct 1, 2020

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Details of clinical, biological, imaging, therapeutic characteristics and patient's evolution. [at 6 and 12 months]

   Retrospective collection of clinical, diagnostic and therapeutic data, evolution at 6 and 12 months.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospice Civils de Lyon	Bron		France	69500,

Sponsors and Collaborators

• Hospices Civils de Lyon

Investigators

• Study Director: Jérôme Honnorat, National Reference Center of autoimmune encephalitis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospices Civils de Lyon
• ClinicalTrials.gov Identifier: NCT04339127
• Other Study ID Numbers: NMDARE-HSE
• First Posted: Apr 9, 2020
• Last Update Posted: Apr 9, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Encephalitis, Herpes Simplex; Anti-N-Methyl-D-Aspartate Receptor Encephalitis; Encephalitis; Hashimoto Disease

Study Results

No Results Posted as of Apr 9, 2020