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Comparing the Effects of Anakinra and Tocilizumab on Outcomes in Patients With New-Onset Refractory Status Epilepticus
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.
Age
2 - No limit years
Sex
ALL
Healthy Volunteers
No
Barrow Institute
Phoenix, Arizona, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Children's National (DC)
Washington D.C., District of Columbia, United States
University of Florida
Gainesville, Florida, United States
University of Chicago
Chicago, Illinois, United States
Northwestern University
Evanston, Illinois, United States
Mass General (MGH)
Boston, Massachusetts, United States
Beth Israel Deaconess
Boston, Massachusetts, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Start Date
March 1, 2026
Primary Completion Date
March 31, 2030
Completion Date
September 30, 2030
Last Updated
December 15, 2025
438
ESTIMATED participants
Anakinra
DRUG
Tocilizumab
DRUG
Standard medical treatment
OTHER
Lead Sponsor
Yale University
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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