A multicenter randomized, controlled, double-blinded trial to evaluate efficacy and safety of bortezomib in patients with severe autoimmune encephalitis

Phase 2

Recruiting

Conditions: autoimmune encephalitis
G04
Encephalitis, myelitis and encephalomyelitis

Registration Number: DRKS00017497

Lead Sponsor: Friedrich-Schiller-Universität Jena

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

• Clinical diagnosed severe autoimmune encephalitis (mRS = 3)
• auto-antibodies against neuronal surface proteins in the liquor or serum, proof not older than 4 weeks prior to randomisation
• pretreatment with Rituximab
• Age =18 Jahre
• signed informed consent
• women of childbearing potential (up to 2 years after menopause): negative pregnancy test

Exclusion Criteria

• breast-feeding
• acute infiltrative pulmonary disease
• acute infiltrative pericardial disease
• malignant tumor and current chemotherapy
• current participation in another interventional study
• previous participation in this study
• known hypersensitivity to an ingredient of the investigational product
• continued therapy with glucocorticoids / Rituximab during the study (last administration must be prior to the first dose of the investigational product)

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
modified Rankin-Score 17 weeks after first administration of the trial medication

Secondary Outcome Measures

Name	Time	Method
• mRS and GCS-Scores 3, 6, 9 and 13 weeks after first administration of the trial medication; GCS Score also 17 weeks after first administration of the trial medication <br><br>• Length of in-hospital stay / length of ICU stay <br><br>• Antibody titer and destruction markers (in serum and liquor) <br><br>• cellular immune response (FACS analysis of liquor) at study start and 17 weeks after first administration of the study medication <br><br>• neurocognitive function (MoCA, MMST, RAVLT and NPI) at study start and 17 weeks after first administration of the study medication <br><br>Outcome regarding safety:<br>• Number of serious adverse events from study start until 17 weeks after first administration of the study medication <br><br>• safety of Bortezomib regarding polyneuropathy, increase of liver enzymes, hematotoxicity, gastrointestinal toxicity and secondary infections