A Multicenter Randomized, Controlled, Double-blinded Trial to Evaluate Efficacy and Safety of Bortezomib in Patients With Severe Autoimmune Encephalitis

Who is this study for? Patients with Autoimmune Encephalitis
What treatments are being studied? Bortezomib
Status: Recruiting
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
Charité - Universitätsmedizin Berlin, Klinik für Neurologie mit Experimenteller Neurologie
RECRUITING
Berlin
Ruhr-Universität Bochum, St. Josef Hospital, Klinik für Neurologie
RECRUITING
Bochum
University Hospital Düsseldorf, Clinic for Neurology
RECRUITING
Düsseldorf
Universitätsklinikum Erlangen, Neurologische Klinik
RECRUITING
Erlangen
Universitätsklinikum Essen (AöR), Klinik für Neurologie
RECRUITING
Essen
University Hospital Frankfurt (Main), Clinic for Neurology
RECRUITING
Frankfurt
Universitätsmedizin Göttingen Georg-August-Universität, Klinik für Neurologie
RECRUITING
Göttingen
Universitätsmedizin Greifswald, Klinik und Poliklinik für Neurologie
RECRUITING
Greifswald
Medizinische Hochschule Hannover
RECRUITING
Hanover
Universitätsklinikum Jena, Sektion Translationale Neuroimmunologie, Klinik für Neurologie
RECRUITING
Jena
Klinik für Neurologie UKSH, Campus Kiel
RECRUITING
Kiel
Universitätsklinikum Leipzig, Klinik und Poliklinik für Neurologie
RECRUITING
Leipzig
Universitätsmedizin Mainz, Klinik und Poliklinik für Neurologie
RECRUITING
Mainz
Ludwig-Maximilians-Universität München, Klinikum Großhadern
RECRUITING
München
Universitätsklinikum Münster Klinik für Neurologie
RECRUITING
Münster
Universitätsklinikum Ulm, Klinik für Neurologie Neurologische Ambulanz
RECRUITING
Ulm
Universitätsklinikum Würzburg
RECRUITING
Würzburg
Contact Information
Primary
Christian Geis, Prof.
Christian.Geis@med.uni-jena.de
+49 (0) 3641
Backup
Jonathan Wickel, Dr.
Jonathan.Wickel@med.uni-jena.de
+49 (0) 3641
Time Frame
Start Date: 2020-05-13
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 50
Treatments
Experimental: Interventional
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_comparator: Placebo
1 to 3 cycles placebo (NaCl solution) s.c. + 20mg dexamethasone p.o. on days 1, 4, 8 and 11 (= 1 cycle)
Related Therapeutic Areas
Sponsors
Collaborators: Federal Ministry of Education and Reserach (BMBF)
Leads: Jena University Hospital

This content was sourced from clinicaltrials.gov