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

Conditions

autoimmune encephalitis

Brief summary

mRS 17 weeks after first administration of the investigational product

Detailed description

mRS and GCS 3, 6, 9 and 13 weeks after first administration of the investigational product; GCS 17 weeks after first administration of the investigational product, Length of stay in hospital/intensive care unit, Antibody titers and destruction markers (in serum and cerebrospinal fluid), cellular immune response (FACS, in cerebrospinal fluid) at the baseline visit and 17 weeks after first administration of the investigational product, Neurocognitive function (MoCA, MMST, VLMT and NPI) at the baseline visit and 17 weeks after the first visit and 17 weeks after first administration of the investigational product, Number of all (serious) adverse events within 17 weeks after the first 17 weeks after first administration of the investigational product, Bortezomib safety with regard to polyneuropathy, increase in liver enzymes liver enzymes, hematotoxicity, gastrointestinal toxicity and secondary infections.

Related papers

No related papers found yet.

Interventions

DRUGBORTEZOMIB

DRUGSALINE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
mRS 17 weeks after first administration of the investigational product	—

Secondary

Measure	Time frame
mRS and GCS 3, 6, 9 and 13 weeks after first administration of the investigational product; GCS 17 weeks after first administration of the investigational product, Length of stay in hospital/intensive care unit, Antibody titers and destruction markers (in serum and cerebrospinal fluid), cellular immune response (FACS, in cerebrospinal fluid) at the baseline visit and 17 weeks after first administration of the investigational product, Neurocognitive function (MoCA, MMST, VLMT and NPI) at the baseline visit and 17 weeks after the first visit and 17 weeks after first administration of the investigational product, Number of all (serious) adverse events within 17 weeks after the first 17 weeks after first administration of the investigational product, Bortezomib safety with regard to polyneuropathy, increase in liver enzymes liver enzymes, hematotoxicity, gastrointestinal toxicity and secondary infections.	—

Measure

Time frame

mRS and GCS 3, 6, 9 and 13 weeks after first administration of the investigational product; GCS 17 weeks after first administration of the investigational product, Length of stay in hospital/intensive care unit, Antibody titers and destruction markers (in serum and cerebrospinal fluid), cellular immune response (FACS, in cerebrospinal fluid) at the baseline visit and 17 weeks after first administration of the investigational product, Neurocognitive function (MoCA, MMST, VLMT and NPI) at the baseline visit and 17 weeks after the first visit and 17 weeks after first administration of the investigational product, Number of all (serious) adverse events within 17 weeks after the first 17 weeks after first administration of the investigational product, Bortezomib safety with regard to polyneuropathy, increase in liver enzymes liver enzymes, hematotoxicity, gastrointestinal toxicity and secondary infections.

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Countries

Germany

Outcome results

None listed