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NCT04372615 · ClinicalTrials.gov registry record · Phase 2
The ExTINGUISH Trial of Inebilizumab in NMDAR Encephalitis
A Phase 2 study of Encephalitis and Autoimmune Encephalitis, sponsored by University of Utah.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 116
- Enrollment target
- 20
- Study locations
NCT04372615: Recruiting Phase 2 study of Encephalitis and Autoimmune Encephalitis, sponsored by University of Utah.
NCT04372615 is a Phase 2 study of Encephalitis and Autoimmune Encephalitis that is actively recruiting participants, run by University of Utah. The registered enrollment target is 116 participants, below the 764-participant average among 4 other Encephalitis trials with a reported enrollment target (85% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04372615, a Phase 2 study of Encephalitis and Autoimmune Encephalitis, is actively recruiting participants, sponsored by University of Utah.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 116 participants
- Enrollment target
- 20
- Study locations
Study Summary
Determine the difference in the modified Rankin score at 16 weeks in participants with anti-N-methyl-D-aspartate receptor (NMDAR) encephalitis treated with "first-line" immunomodulatory therapies provided as standard-of-care, and either inebilizumab (investigational agent) or placebo.
Primary Outcome
Change in modified Rankin score (mRS) (0 to 6; 0=normal and 6=death) at 16 weeks determined by rank analyses, integrating need for rescue therapy and time to achievement of the mRS.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Inebilizumab
Study Locations (20)
California
- Children's Hospital of Orange County - Orange
- UC Irvine - Orange
- UC Davis - Sacramento
Arizona
- St. Joseph Hospital and Medical Center Barrow Neurological Institute - Phoenix
- Mayo Clinic in Arizona - Scottsdale
Colorado
- Children's Hospital Colorado Main Campus - Aurora
- University of Colorado - Aurora
Florida
- Mayo Clinic Jacksonville - Jacksonville
- University of Miami - Miami
Illinois
- Ann and Robert H. Lurie Childrens Hospital of Chicago - Chicago
- Northwestern University Feinberg School of Medicine - Chicago
Alabama
- University of Alabama at Birmingham - Birmingham
Connecticut
- Yale University - New Haven
Georgia
- Emory University - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2022-03-30 |
| Est. Completion | 2028-09-30 |
| Phase | Phase 2 |
What NCT04372615 shows while recruiting
NCT04372615 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, below the 764-participant average among 4 other Encephalitis trials with a reported enrollment target (85% lower).
The record links to 2 conditions, with Encephalitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04372615 names 20 study sites across 14 states, led by California, Arizona, Colorado.
Frequently Asked Questions
What is clinical trial NCT04372615 about?
NCT04372615 is a clinical study titled "The ExTINGUISH Trial of Inebilizumab in NMDAR Encephalitis". Determine the difference in the modified Rankin score at 16 weeks in participants with anti-N-methyl-D-aspartate receptor (NMDAR) encephalitis treated with "first-line" immunomodulatory therapies provided as standard-of-care, and either inebilizumab (investigational agent) or placebo.
What is the current status of trial NCT04372615?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 116 participants. The study started on 2022-03-30. Estimated completion is 2028-09-30.
What conditions does trial NCT04372615 study?
This clinical trial studies the following conditions: Encephalitis, Autoimmune Encephalitis.
What interventions are being tested in trial NCT04372615?
The interventions under investigation include: Placebo (DRUG), Inebilizumab (DRUG).
Who is sponsoring clinical trial NCT04372615?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04372615 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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