Actively Recruiting
Medium-term Effects of Treatments in Autoimmune Encephalitis (META): a Real-life, Observational Prospective Study
Led by Hospices Civils de Lyon · Updated on 2025-08-20
200
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Autoimmune encephalitides are serious neurological disorders that require urgent treatment, but there is no standard guideline due to a lack of strong evidence. Treatments are usually divided into first-line therapies, such as steroids and intravenous immunoglobulins, and second-line therapies including rituximab and cyclophosphamide. This study aims to assess the clinical response to commonly used treatment initiation protocols in patients with various types of autoimmune encephalitis, including NMDAR, LGI1, CASPR2, IgLON5, GFAP, and GAD65 encephalitis. Researchers want to understand if starting with dual immunosuppression is necessary for all patients or if it should be reserved for those who do not respond to initial treatment. Patients newly diagnosed with these types of autoimmune encephalitis who have not yet been treated or have started treatment within the last 30 days will be included. Treatment protocols will be categorized as first-line only, first-line with rituximab, rituximab combined with cyclophosphamide, or other approaches. Data will be collected through standardized questionnaires sent to clinicians at the start of therapy and again four months later. These questionnaires cover demographics, symptoms, cognitive tests, level of dependence, social impact, and diagnostic tests such as brain MRI, PET scans, cerebrospinal fluid analysis, and EEG. Participants will be followed through two main visits: one at baseline and another four months after starting treatment. Researchers will monitor treatment failure as the primary outcome during this period. Information on cognitive function, daily living activities, and diagnostic findings will help assess the impact of treatments. The study involves real-life observation of treatment effects to better understand how patients respond over the medium term, with data collected through routine clinical management and expert multidisciplinary team meetings conducted every two months.
CONDITIONS
Brief Title
Medium-term Effects of Treatments in Autoimmune Encephalitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult or child patient with encephalitis defined as anti-GAD, NMDAR, LGI1, CASPR2, IgLON5 or GFAP
- Untreated or with a decision to treat within the previous 30 days
You will not qualify if you...
- Refusal by the referring doctor to participate or refusal by the patient mentioned in the objection to the use of his/her clinical data
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for eligibility assessment
Duration - 4 months
Participants are observed to assess the clinical response to the treatment initiation protocols commonly used in autoimmune encephalitis.
2 visits: baseline visit at treatment initiation and 1 follow-up visit 4 months later
Trial Site Locations
Total: 1 location
1
Hospices Civil de Lyon
Bron, France, 69677
Actively Recruiting
Research Team
B
Bastien Pr JOUBERT
G
Géraldine PICARD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
6
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here