Predicting Functional Outcome and Response to Therapy of Anti-NMDAR Encephalitis at Diagnosis
NCT ID: NCT06023160
Last Updated: 2025-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
714 participants
OBSERVATIONAL
2020-12-01
2024-07-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Validation of a Diagnostic Score for Encephalitis to Assess the Risk of Autoimmune Origin
NCT05953974
Efficacy and Safety of Enteric-coated Mycophenolate Sodium in Combination With Two Corticosteroid Regimens for the Treatment of Lupus Nephritis Flare
NCT00423098
Phase II Study of Long-Term Dehydroepiandrosterone for Systemic Lupus Erythematosus
NCT00004665
New Biomarkers in Auto-immune Encephalitis and Neurological Paraneoplastic Syndromes
NCT05728931
Monitoring of Azathioprine Metabolite Concentrations and Cytokine Levels in Neuromyelitis Optica Spectrum Disorder
NCT05896605
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The investigators strive to have less than 10% missing data on all variables and will impute data were needed. The datasets will then be split - with equal distributions of cohorts and good/poor outcome - to develop (70%) and validate (30%) the NEOS2 model. The primary outcome is functioning one year after diagnosis. A secondary analysis is targeted to predict the effect of first-line therapy. Potentially relevant predictive variables are identified with a univariable analysis on the original data, confirmed with backwards selection on the imputed datasets. After checking for multicollinearity and linearity of the variables, identified variables are added to a mixed effects logistic regression model on the original and imputed datasets, to identify the final set of predictive variables. To make the models opportune for daily medical practice, the investigators will assign points to (categories of) the included variables, based on the coefficients.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dutch National anti-NMDAR Encephalitis Cohort
Dutch National anti-NMDAR Encephalitis Cohort
No interventions assigned to this group
German anti-NMDAR Encephalitis Cohort (GENERATE)
German anti-NMDAR Encephalitis Cohort (GENERATE)
No interventions assigned to this group
Spanish anti-NMDAR Encephalitis Cohort
Spanish anti-NMDAR Encephalitis Cohort
No interventions assigned to this group
French anti-NMDAR Encephalitis Cohort
French anti-NMDAR Encephalitis Cohort
No interventions assigned to this group
Japanese anti-NMDAR Encephalitis Cohort
Japanese anti-NMDAR Encephalitis Cohort
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Premorbid dependency (modified Rankin Scale \> 2)
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Erasmus Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr. Maarten J. Titulaer. MD, PhD
Associate professor, Dr.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Maarten J. Titulaer, Assoc. Porf.
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Erasmus Medical Center
Rotterdam, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NEOSII
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.