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

Study acronym: COMBAT-NORSE
StatusNot Yet Recruiting
PhasePhase 3
Started2026-12-01
View on ClinicalTrials.gov ↗

Amendment history

2026-08-18
minor
Study Status v2
Start date2026-07-01→2026-12-01
2026-05-08
minor
Study Status v1
Start date2026-03-01→2026-07-01
2025-12-03
minor
Original filing
487 trials monitored
See 35 trials at risk
723 trials monitored
See 41 trials at risk
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.
Trial Details
NCT Number NCT07281027
Lead Sponsor Yale University
Collaborators: Patient-Centered Outcomes Research Institute
Conditions New Onset Refractory Status Epilepticus, New-Onset Refractory Status Epilepticus, Febrile Infection-Related Epilepsy Syndrome (FIRES)
Enrollment 438 participants
Start Date 2026-12-01
Primary Completion 2030-03-31 (estimated)
Study Completion 2030-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-19