Clinical Research Directory
Browse clinical research sites, groups, and studies.
Trial to Evaluate Efficacy and Safety of Bortezomib in Patients With Severe Autoimmune Encephalitis
Sponsor: Jena University Hospital
Summary
Autoimmune Encephalitis is a disorder of the central nervous system caused by bodily substances, called antibodies. Antibodies normally help the body to prevent infections. However, in this disorder, the antibodies turn against the body itself and especially against cells in the brain and disturb the normal brain function. They are therefore called autoantibodies. There is no specific therapy for patients with autoimmune encephalitis so far. At the moment, the symptoms are treated with approved medications such as cortisone and immunotherapies also used in oncology. These therapies are unspecified and aim to reduce the number of autoantibodies and to contain the autoimmune process. In this trial we aim to test a new therapy option: in this therapy the body cells producing autoantibodies will be specifically targeted by a substance called bortezomib. The trial addresses patients with severe autoimmune encephalitis. The aim of the trial is to evaluate the efficacy and safety of bortezomib in patients with severe autoimmune encephalitis.
Official title: A Multicenter Randomized, Controlled, Double-blinded Trial to Evaluate Efficacy and Safety of Bortezomib in Patients With Severe Autoimmune Encephalitis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2020-05-13
Completion Date
2026-12-31
Last Updated
2025-09-04
Healthy Volunteers
No
Conditions
Interventions
Bortezomib
1 to 3 cycles Bortezomib with 1,3mg/m2 body surface s.c. + 20mg dexamethasone p.o. on days 1, 4, 8 and 11 (= 1 cycle)
Placebo
1 to 3 cycles placebo (NaCl solution) s.c. + 20mg dexamethasone p.o. on days 1, 4, 8 and 11 (= 1 cycle)
Locations (17)
Ludwig-Maximilians-Universität München, Klinikum Großhadern
München, Bavaria, Germany
Universitätsklinikum Würzburg
Würzburg, Bavaria, Germany
Universitätsklinikum Jena, Sektion Translationale Neuroimmunologie, Klinik für Neurologie
Jena, Germany, Germany
Medizinische Hochschule Hannover
Hanover, Niedersachen, Germany
Charité - Universitätsmedizin Berlin, Klinik für Neurologie mit Experimenteller Neurologie
Berlin, Germany
Ruhr-Universität Bochum, St. Josef Hospital, Klinik für Neurologie
Bochum, Germany
University Hospital Düsseldorf, Clinic for Neurology
Düsseldorf, Germany
Universitätsklinikum Erlangen, Neurologische Klinik
Erlangen, Germany
Universitätsklinikum Essen (AöR), Klinik für Neurologie
Essen, Germany
University Hospital Frankfurt (Main), Clinic for Neurology
Frankfurt, Germany
Universitätsmedizin Göttingen Georg-August-Universität, Klinik für Neurologie
Göttingen, Germany
Universitätsmedizin Greifswald, Klinik und Poliklinik für Neurologie
Greifswald, Germany
Klinik für Neurologie UKSH, Campus Kiel
Kiel, Germany
Universitätsklinikum Leipzig, Klinik und Poliklinik für Neurologie
Leipzig, Germany
Universitätsmedizin Mainz, Klinik und Poliklinik für Neurologie
Mainz, Germany
Universitätsklinikum Münster Klinik für Neurologie
Münster, Germany
Universitätsklinikum Ulm, Klinik für Neurologie Neurologische Ambulanz
Ulm, Germany