NCT05953974

Brief Summary

The investigators wish to test a diagnostic risk score for autoimmune encephalitis in case of encephalitis, previously validated by two American teams, in a retrospective analysis, according to the clinical and paraclinical data available in our database of the Reference Centre for Autoimmune Encephalitis and Paraneoplastic Neurological Syndromes of Professor Honnorat for patients with NMDAr, anti LGi1, anti CASPR2, anti GABAbr and anti GAD antibodies.

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
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

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

February 1, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 20, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

November 13, 2023

Status Verified

June 1, 2023

Enrollment Period

Same day

First QC Date

June 27, 2023

Last Update Submit

November 9, 2023

Conditions

Keywords

Diagnostic scoreauto-immune encephalitis

Outcome Measures

Primary Outcomes (6)

  • Validation of a diagnostic score for encephalitis to assess the risk of autoimmune origin.

    Comorbidities assessed by the Charlson score

    At baseline

  • Symptoms in the acute phase

    At baseline

  • Mode of onset of disease

    At baseline

  • Results of lumbar puncture

    At baseline

  • Results of antineuronal antibodies in CSF

    At baseline

  • Results of antineuronal antibodies in serum

    At baseline

Study Arms (5)

NMDAr patients

Patients \> or = 18 years old presenting with auto-immune encephalitis, defined according to the Graus criteria, with neuronal antibodies : \- Anti NMDAr

Other: Clinical score of Granillo and al.

LGI1 patients

Patients \> or = 18 years old presenting with auto-immune encephalitis, defined according to the Graus criteria, with neuronal antibodies : \- Anti LGI1

Other: Clinical score of Granillo and al.

CASPR2 patients

Patients \> or = 18 years old presenting with auto-immune encephalitis, defined according to the Graus criteria, with neuronal antibodies : \- Anti CASPR2

Other: Clinical score of Granillo and al.

GABAb patients

Patients \> or = 18 years old presenting with auto-immune encephalitis, defined according to the Graus criteria, with neuronal antibodies : \- Anti GABAb

Other: Clinical score of Granillo and al.

GAD patients

Patients \> or = 18 years old presenting with auto-immune encephalitis, defined according to the Graus criteria, with neuronal antibodies : \- Anti GAD

Other: Clinical score of Granillo and al.

Interventions

Compare the performance of the clinical prediction score of confirmed autoimmune encephalitis according to the type of antibody isolated from the CSF.

CASPR2 patientsGABAb patientsGAD patientsLGI1 patientsNMDAr patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients \> or = 18 years old presenting with auto-immune encephalitis, defined according to the Graus criteria, with neuronal antibodies : * Anti NMDAr * Anti LGI1 * Anti CASPR2 * Anti GABAb * Anti GAD

You may qualify if:

  • Age \> 18 years old
  • Patient with a definite auto-immune encephalitis (Graus and al. 2016)

You may not qualify if:

  • Uncomplete data in acute phase
  • Patient with several antibodies
  • Opposition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes

Lyon, France

Location

MeSH Terms

Conditions

Autoimmune Diseases of the Nervous System

Condition Hierarchy (Ancestors)

Nervous System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

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

Study Record Dates

First Submitted

June 27, 2023

First Posted

July 20, 2023

Study Start

February 1, 2023

Primary Completion

February 1, 2023

Study Completion

December 30, 2023

Last Updated

November 13, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations