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NCT07281027 · ClinicalTrials.gov registry record · Phase 3
COMparison Between Anakinra and Tocilizumab in NORSE - "COMBAT-NORSE"
A Phase 3 study, sponsored by Yale University.
- Not yet
- Registry status
- Phase 3
- Development phase
- 438
- Enrollment target
NCT07281027 is a Phase 3 study that has not yet begun recruiting, run by Yale University. The registered enrollment target is 438 participants.
The verdict
NCT07281027, a Phase 3 study, has not yet begun recruiting, sponsored by Yale University.
- NOT YET RECRUITING
- Registry status
- Phase 3
- Development phase
- 438 participants
- Enrollment target
Study Summary
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.
Interventions
- OTHER Standard medical treatment
- DRUG Anakinra
- DRUG Tocilizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 438 participants |
| Start Date | 2026-07-01 |
| Est. Completion | 2030-09-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07281027
The ClinicalTrials.gov registry entry for NCT07281027 describes a study currently listed as not yet recruiting, categorized as Phase 3. The registered enrollment target is 438 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Standard medical treatment is the first listed.
NCT07281027 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07281027 about?
NCT07281027 is a clinical study titled "COMparison Between Anakinra and Tocilizumab in NORSE - "COMBAT-NORSE"". 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 adult...
What is the current status of trial NCT07281027?
This trial is currently not yet recruiting. It is a Phase 3 study. The enrollment target is 438 participants. The study started on 2026-07-01. Estimated completion is 2030-09-30.
What interventions are being tested in trial NCT07281027?
The interventions under investigation include: Standard medical treatment (OTHER), Anakinra (DRUG), Tocilizumab (DRUG).
Who is sponsoring clinical trial NCT07281027?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
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