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Tests treatment safety and results for Autoimmune Encephalitis
Official title Trial to Evaluate Efficacy and Safety of Bortezomib in Patients With Severe Autoimmune Encephalitis
ClinicalTrials.gov ID: NCT03993262
What this study is testing
What is Bortezomib?
Bortezomib is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for autoimmune encephalitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Autoimmune Encephalitis is a disorder of the central nervous system caused by bodily substances, called antibodies. Antibodies normally help the body to prevent infections.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Clinically diagnosed severe autoimmune encephalitis (defined as mRS ≥ 3) with autoantibodies to neuronal surface proteins in cerebrospinal fluid and...
- Pretreatment with rituximab
- Age ≥18 years
- signed informed consent
- Women of childbearing potential (up to 2 years after menopause): negative pregnancy test
You likely can't join if
- pregnancy/breast-feeding
- acute infiltrative pulmonary and pericardial disease
- malignant tumor under current chemotherapy
- Simultaneous participation in another intervention study
- Previous participation in this study
- Known hypersensitivity to an ingredient of the investigational product
See the full eligibility criteria
- Clinically diagnosed severe autoimmune encephalitis (defined as mRS ≥ 3) with autoantibodies to neuronal surface proteins in cerebrospinal fluid and / or serum
- Pretreatment with rituximab
- Age ≥18 years
- signed informed consent
- Women of childbearing potential (up to 2 years after menopause): negative pregnancy test
- pregnancy/breast-feeding
- acute infiltrative pulmonary and pericardial disease
- malignant tumor under current chemotherapy
- Simultaneous participation in another intervention study
- Previous participation in this study
- Known hypersensitivity to an ingredient of the investigational product
- Continued therapy with glucocorticoids / rituximab during the study duration (last dose must be administered before the first dose of the investigational product)
The study team makes the final eligibility decision.
Where it's taking place
- München, Bavaria, Germany
- Würzburg, Bavaria, Germany
- Jena, Germany, Germany
- Hanover, Niedersachen, Germany
- Berlin, Germany
- Bochum, Germany
- Düsseldorf, Germany
- Erlangen, Germany
- Essen, Germany
- Frankfurt, Germany
- Göttingen, Germany
- Greifswald, Germany
- Kiel, Germany
- Leipzig, Germany
- Mainz, Germany
- Münster, Germany
- Ulm, Germany
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include München, Bavaria, Germany; Würzburg, Bavaria, Germany; Jena, Germany, Germany; Hanover, Niedersachen, Germany; Berlin, Germany; Bochum, Germany and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.