NCT04339127

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 9, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

April 9, 2020

Status Verified

April 1, 2020

Enrollment Period

2 months

First QC Date

April 6, 2020

Last Update Submit

April 6, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    at 6 and 12 months

Study Arms (1)

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

Interventions

Retrospective, non-interventional study, using clinical, biological, radiological and therapeutic data collected during the initial diagnosis and follow-up.

Cohort NMDARE-HSE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

12 patients diagnosed between January 2014 and January 2020

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospice Civils de Lyon

Bron, 69500,, France

RECRUITING

MeSH Terms

Conditions

Autoimmune Diseases of the Nervous SystemAnti-N-Methyl-D-Aspartate Receptor EncephalitisEncephalitis, Herpes Simplex

Condition Hierarchy (Ancestors)

Nervous System DiseasesAutoimmune DiseasesImmune System DiseasesParaneoplastic Syndromes, Nervous SystemNervous System NeoplasmsNeoplasms by SiteNeoplasmsParaneoplastic SyndromesEncephalitisBrain DiseasesCentral Nervous System DiseasesNeurodegenerative DiseasesNeuroinflammatory DiseasesEncephalitis, ViralCentral Nervous System Viral DiseasesCentral Nervous System InfectionsInfectionsInfectious EncephalitisVirus DiseasesHerpesviridae InfectionsDNA Virus Infections

Study Officials

  • Jérôme Honnorat

    National Reference Center of autoimmune encephalitis

    STUDY DIRECTOR

Central Study Contacts

Jérôme Honnorat, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2020

First Posted

April 9, 2020

Study Start

April 1, 2020

Primary Completion

June 1, 2020

Study Completion

October 1, 2020

Last Updated

April 9, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations