COMparison Between Anakinra and Tocilizumab in NORSE - "COMBAT-NORSE"

ClinicalTrials.gov ID: NCT07281027

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.

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ClinicalTrials.gov public records Last synced Oct 21, 2026, 9:08 AM EDT

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
Lead sponsor: Yale University; Other
Enrollment: 438 participants

Conditions and interventions

Conditions

Interventions

Drug · Other

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: Dec 1, 2026 (Estimated)
Primary completion: Mar 31, 2030 (Estimated)
Completion: Sep 30, 2030 (Estimated)
Last update posted: Aug 19, 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 19, 2026 · Synced Oct 21, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT07281027 live on ClinicalTrials.gov.

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