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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: Clinical Trial Phase 2 study, sponsored by University of Texas Southwestern Medical Center.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The number of participants who had clinical worsening within 12 months.
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 |
Why NCT03835728 stopped before completion
NCT03835728 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Saline is the first listed.
NCT03835728 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03835728's enrollment target sits among peer trials
3 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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