Status:
TERMINATED
Efficacy of Ocrelizumab in Autoimmune Encephalitis
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Autoimmune Encephalitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This pilot study is a randomized, double-blind, placebo controlled study of the efficacy of ocrelizumab in autoimmune encephalitis. Subjects with new diagnosis of autoimmune encephalitis will be invit...
Eligibility Criteria
Inclusion
- Age 18 or greater
- Able to obtain informed consent from patient or appropriate designee
- Possible autoimmune encephalitis as defined by Table 1:
- Reasonable exclusion of alternative causes
- Subacute onset (\< 3 months) of memory deficits, altered consciousness, and/or psychiatric symptoms
- One or more of the following:
- CSF (cerebrospinal fluid) pleocytosis (\>5 cells/µl corrected, if necessary, for traumatic lumbar puncture)
- EEG (electroencephalogram) with epileptiform or focal slow wave abnormalities involving temporal lobes
- Brain abnormalities on T2/FLAIR MRI restricted to the mesial temporal (limbic) lobes
- Associated dyskinesias (faciobrachial dystonic movements or orofacial dyskinesias)
- Completed initial treatment with iv steroids (at least 3000mg solumedrol) and plasma exchange (at least 3 exchanges) within the past 8 weeks
- Presence of one (or more) of the following autoantibodies in serum or CSF
- NMDA receptor
- LGI1
- CASPR2
- DPPX
Exclusion
- Prior immunosuppression treatment in past year (other than steroids, intravenous immunoglobulin and plasma exchange)
- Active malignancy requiring chemotherapy
- Pregnancy
- Evidence of active hepatitis or tuberculosis infection
- Medical condition that (in investigators opinion) precludes the use of ocrelizumab
Key Trial Info
Start Date :
January 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 2 2020
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT03835728
Start Date
January 22 2019
End Date
October 2 2020
Last Update
October 19 2021
Active Locations (1)
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1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390