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A Multicenter Randomized, Controlled, Double-blinded Trial to Evaluate Efficacy and Safety of Bortezomib in Patients With Severe Autoimmune Encephalitis
EU CTIS ID: 2024-514494-21-00
What this study is testing
Evaluation of the efficacy and safety of bortezomib in patients with severe autoantibody-positive autoimmune encephalitis
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.