At a glance
ClinicalIndex Comparison Record- ✓Clinically diagnosed severe autoimmune encephalitis with mRS score ≥3
- ✓Autoantibodies to neuronal surface proteins in CSF and/or serum
- ✓Prior treatment with rituximab
- ✓Age 18 years or older
- ✕Pregnancy or breast-feeding
- ✕Acute infiltrative pulmonary and pericardial disease
- ✕Malignant tumor under current chemotherapy
- ✕Simultaneous participation in another intervention study
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter Randomized, Controlled, Double-blinded Trial to Evaluate Efficacy and Safety of Bortezomib in Patients With Severe Autoimmune Encephalitis
In Brief
A Phase 2 clinical trial evaluating Bortezomib and Placebo for Autoimmune Encephalitis. Currently recruiting, targeting 50 participants across 17 sites.
Detailed 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.
Study Details
Timeline
Interventions
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)
1 to 3 cycles placebo (NaCl solution) s.c. + 20mg dexamethasone p.o. on days 1, 4, 8 and 11 (= 1 cycle)