COMparison Between Anakinra and Tocilizumab in NORSE - "COMBAT-NORSE"
Public ClinicalTrials.gov record NCT07281027. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Comparing the Effects of Anakinra and Tocilizumab on Outcomes in Patients With New-Onset Refractory Status Epilepticus
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The goal of this clinical trial is to find out whether two existing medications-anakinra and tocilizumab-can effectively treat a rare and life-threatening brain condition called NORSE (New-Onset Refractory Status Epilepticus). NORSE causes continuous seizures in previously healthy children and adults and does not respond to standard treatments. It often leads to long-term disability or death. Doctors currently use anakinra and tocilizumab as second-line treatments when first-line therapies fail, but there is no clear evidence showing which drug works better or when it should be given. This study aims to answer those questions. The study will enroll patients across 33 hospitals in the United States, Canada, Europe, and Asia. It includes two groups: 1. Randomized Cohort Patients will be randomly assigned to receive either anakinra or tocilizumab within the first 7 days of their illness. Only patients whose doctors were already planning to use one of these medications as part of standard care will be eligible for randomization. Researchers will monitor their recovery and compare outcomes between the two treatments. 2. Observational Cohort Patients who cannot be randomized-usually because they were diagnosed too late-will still be followed to study how the timing of treatment affects recovery. Participants will: * Receive one of the two medications (depending on their group assignment). * Take part in follow-up assessments over the course of one year, including medical evaluations and surveys. Some participants may be followed annually beyond one year. * Optionally participate in a 60-minute interview to share their or their caregiver's experience with NORSE.
Study identification
- NCT ID
- NCT07281027
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 438 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 2026
- Primary completion
- Mar 30, 2030
- Completion
- Sep 29, 2030
- Last update posted
- Aug 18, 2026
2026 – 2030
United States locations
- U.S. sites
- 25
- U.S. states
- 16
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Barrow Institute | Phoenix | Arizona | 85013 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Yale New Haven Hospital | New Haven | Connecticut | 06520 | — |
| Children's National (DC) | Washington D.C. | District of Columbia | 20010 | — |
| University of Florida | Gainesville | Florida | 32611 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Northwestern University | Evanston | Illinois | 60208 | — |
| Mass General (MGH) | Boston | Massachusetts | 02114 | — |
| Beth Israel Deaconess | Boston | Massachusetts | 02215 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02215 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| University of Nebraska | Lincoln | Nebraska | 68588 | — |
| New York University | New York | New York | 10012 | — |
| Columbia University | New York | New York | 10027 | — |
| Mount Sinai (NY) | New York | New York | 10029 | — |
| University of Cincinnati | Cincinnati | Ohio | 45221 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| Children's Hospital Philadelphia (CHOP) | Philadelphia | Pennsylvania | 19104 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Baylor/Texas Children's | Houston | Texas | 77030 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
| University of Wisconsin | Madison | Wisconsin | 53706 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 8 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07281027, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 18, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07281027 live on ClinicalTrials.gov.