CTIS2024-514494-21-00
Active, not recruiting
Phase 1
A Multicenter Randomized, Controlled, Double-blinded Trial to Evaluate Efficacy and Safety of Bortezomib in Patients With Severe Autoimmune Encephalitis - ZKSJ0120
Friedrich-Schiller-Universitaet Jena0 sites50 target enrollmentJune 12, 2024
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- autoimmune encephalitis
- Sponsor
- Friedrich-Schiller-Universitaet Jena
- Enrollment
- 50
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Clinically diagnosed severe autoimmune encephalitis (defined as mRS \= 3\), Autoantibodies against neuronal surface proteins in cerebrospinal fluid or serum serum, detection must not be older than 4 weeks, calculated before randomization, Pre\-treatment with rituximab, Age \= 18 years, Written informed consent of the patient or the patient under witness” (if the patient cannot write for motor reasons) cannot write themselves) or the legal representative (\=guardian) or the authorized representative, Potentially fertile patient (up to 2 years after menopause): negative pregnancy test
Exclusion Criteria
- •Lactation, Acute infiltrative lung disease, Acute infiltrative pericardial disease, Malignant tumor under ongoing or newly started chemotherapy, Concurrent participation in another intervention study, Previous participation in this study, Known hypersensitivity to any ingredient of the investigational product, Continued therapy with glucocorticoids/rituximab during the duration of the study (last administration must be completed before first administration of investigational product)
Outcomes
Primary Outcomes
Not specified
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