Can two arthritis drugs stop deadly brain seizures? major trial launches
NCT ID NCT07281027
First seen Jun 27, 2026 · Last updated Aug 20, 2026 · Updated 2 times
Summary
This Phase 3 trial tests two existing anti-inflammatory drugs, anakinra and tocilizumab, in 438 patients with NORSE, a rare condition causing continuous seizures that don't respond to standard treatments. Patients are randomly assigned to one drug within 7 days of illness, and researchers track recovery over a year. The goal is to find which drug works better and when to give it.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- anakinra and tocilizumab
- What this could lead to
- If this trial succeeds, it could show which existing drug works better for NORSE, potentially improving recovery and reducing disability or death from this rare brain condition.
- What could go wrong
- This is a Phase 3 trial, but NORSE is rare and hard to diagnose early. The study may not enroll enough patients or find a clear difference between the two drugs. Both medications have known side effects like infection risk.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 438 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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2 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 2 and older. * In their usual state of health prior to their onset of SE. * Presenting with NORSE as defined in the consensus criteria: 1. Refractory SE (failed 2 appropriately used anti-seizure medications) in a patient without active epilepsy or other pre-existing relevant neurological disorder and without an acute or active structural, toxic, or metabolic cause found in the first 72 hours. 2. Includes patients with any RSE, not just super-refractory SE. 3. Includes patients who ultimately are discovered to have a known etiology (infectious, autoimmune, genetic, etc.), as well as those who remain cryptogenic. * Additional Inclusion Criteria for the Randomized Arm: * Anakinra and/or tocilizumab are being planned or considered as part of standard clinical care. * The onset of SE was in the prior 7 days at the time of enrollment. Exclusion Criteria: * Any acute or active systemic medical illness such as metastatic cancer, renal failure, hepatic failure, poorly controlled diabetes, etc., in the opinion of the investigators. If this is unclear, the study PI Dr. Hirsch will determine if this criterion is met. Additional Exclusion Criteria for the Randomized Control Cohort: * Contraindication to either anakinra or tocilizumab as listed in the prescribing information: 1. Known hypersensitivity to E. Coli-derived proteins, anakinra, tocilizumab, or any component of the products 2. Active serious infection at the time of initiation 3. Concomitant use of TNF blocking agents; absolute neutrophil count \< 2000; platelet count \< 100,000 per mm³; or ALT or AST \> 1.5 X the upper limit of normal 4. Elevated risk of GI perforation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
33 sites in 7 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Barrow Institute
Phoenix, Arizona, 85013, United States
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Baylor/Texas Children's
Houston, Texas, 77030, United States
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Beth Israel Deaconess
Boston, Massachusetts, 02215, United States
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Boston Children's Hospital
Boston, Massachusetts, 02215, United States
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Children's Hospital Colorado
Aurora, Colorado, 80045, United States
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Children's Hospital Philadelphia (CHOP)
Philadelphia, Pennsylvania, 19104, United States
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Children's National (DC)
Washington D.C., District of Columbia, 20010, United States
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Cleveland Clinic
Cleveland, Ohio, 44195, United States
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Columbia University
New York, New York, 10027, United States
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Great Ormond Street Hospital
London, United Kingdom
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Hospital for Sick Children
Toronto, Canada
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Karolinska Institute
Stockholm, Sweden
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King's College
London, United Kingdom
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Mass General (MGH)
Boston, Massachusetts, 02114, United States
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
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Mount Sinai (NY)
New York, New York, 10029, United States
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New York University
New York, New York, 10012, United States
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Northwestern University
Evanston, Illinois, 60208, United States
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Oregon Health and Science University
Portland, Oregon, 97239, United States
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Salpêtrière
Paris, France
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Seattle Children's Hospital
Seattle, Washington, 98105, United States
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Seoul National University Hospital
Seoul, South Korea
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UT Southwestern Medical Center
Dallas, Texas, 75390, United States
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University of Chicago
Chicago, Illinois, 60637, United States
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University of Cincinnati
Cincinnati, Ohio, 45221, United States
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University of Florida
Gainesville, Florida, 32611, United States
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University of Modena
Modena, Italy
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University of Nebraska
Lincoln, Nebraska, 68588, United States
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University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
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University of Wisconsin
Madison, Wisconsin, 53706, United States
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Western University
London, Canada
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Yale New Haven Hospital
New Haven, Connecticut, 06520, United States