Clinical-immunological Features of Anti-NMDAR Encephalitis

Anti NMDA Receptor Encephalitis Clinical Trial

— Bio-NMDAr  

Official title:

Clinical-immunological Features of Anti-NMDAR Encephalitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05738668
• Other study ID #: 750
• Status: Active, not recruiting
• Start date: February 1, 2022
• Est. completion date: February 1, 2025

Study information

• Verified date: September 2022
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Using a retrospective cohort of 501 patients with anti-NMDAR encephalitis to assess clinical and immunological prognostic biomarkers

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: February 1, 2025
• Est. primary completion date: October 1, 2022
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patient with neurological disorder
• Patient with NMDAR antibodies in sera or CSF

Exclusion Criteria:

• - No available clinical data
• Patient without NMDAR antibodies or neurological disorder

Related Conditions & MeSH terms

• Anti NMDA Receptor Encephalitis
• Anti-N-Methyl-D-Aspartate Receptor Encephalitis
• Encephalitis

Intervention

Other:
• Description of clinical characteristic
This is a non-interventional study involving clinical data and biological samples (blood, DNA, CSF). Clinical data are collected for the center and samples are already stored in biobank repositories and collected as part of "good clinical practice" in the diagnostic process of patients with suspected autoimmune encephalitis, meaning that the standard diagnostic and therapeutic approaches will not be altered in the selected study population. Patients have already gave explicit written consent for biological specimens sampling and storage at the "Centre de Ressources Biologiques des Hospices Civils de Lyon" (CRB-HCL) (including tissue, cells or biological fluids) and genetic analysis for research purposes. Additionally, patients will be informed about the present study.

Locations

Country	Name	City	State
France	Hôpital Neurologique Pierre Wertheimer / Groupement Hospitalier Est	Lyon	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Rankin scale (mRS)	Scale for measuring the degree of dependence in the daily activities of people who have suffered of neurological disability.; 0 - No symptoms.; - No significant disability. Able to carry out all usual activities, despite some symptoms.; - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.; - Moderate disability. Requires some help, but able to walk unassisted.; - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.; - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.; - Dead.	Baseline