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NCT03835728 · ClinicalTrials.gov registry record · Phase 2
Efficacy of Ocrelizumab in Autoimmune Encephalitis
A Phase 2 study, sponsored by University of Texas Southwestern Medical Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT03835728 is a Phase 2 study that was terminated before completion, run by University of Texas Southwestern Medical Center. The registered enrollment target is 3 participants.
The verdict
NCT03835728, a Phase 2 study, was terminated before completion, sponsored by University of Texas Southwestern Medical Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study 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 invited to enroll in this study. Subjects will be randomized to receive ocrelizumab (an anti-CD20 therapy) or matched placebo, and will undergo three infusions over a six month period. Subjects will complete clinical visits over the study period, during which safety monitoring and neuropsychological assessments will be performed to assess for signs of clinical worsening from encephalitis. The primary outcome of this study is the proportion of patients who fail to complete the twelve month period without clinical worsening, as defined by the protocol. Subjects who experience early clinical worsening during the study may be offered open-label treatment with ocrelizumab at the discretion of the investigators.
Interventions
- DRUG Saline
- DRUG Ocrelizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2019-01-22 |
| Est. Completion | 2020-10-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03835728
The ClinicalTrials.gov registry entry for NCT03835728 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Saline is the first listed.
NCT03835728 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03835728 about?
NCT03835728 is a clinical study titled "Efficacy of Ocrelizumab in Autoimmune Encephalitis". 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 invited to enroll in this study. Subjects will be randomized to receive ocrelizumab (an anti-CD20 therapy...
What is the current status of trial NCT03835728?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2019-01-22. Estimated completion is 2020-10-02.
What interventions are being tested in trial NCT03835728?
The interventions under investigation include: Saline (DRUG), Ocrelizumab (DRUG).
Who is sponsoring clinical trial NCT03835728?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
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