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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: Clinical Trial Phase 3 study, sponsored by Yale University.
NCT07281027 is a Phase 3 study that has not yet begun recruiting, run by Yale University. The registered enrollment target is 438 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Glasgow Outcome Scale - Extended (GOS-E) is an 8-point scale used to measure global functional outcome. Participants are scored into one of the 8 categories: 1. Death, 2. Vegetative State, 3. Lower Severe Disability, 4. Upper Severe Disability, 5. Lower Moderate Disability, 6. Upper Moderate Disability, 7. Lower Good Recovery, 8. Upper Good Recovery.
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 |
What is known before NCT07281027 opens enrollment
NCT07281027 is an interventional study that assigns participants to a tested intervention. The registered 438 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 3 interventions - of which Standard medical treatment is the first listed.
NCT07281027 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07281027's enrollment target sits among peer trials
438 874th of 2000 higher than 1,127 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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