Anakinra vs Tocilizumab for Status Epilepticus
(COMBAT-NORSE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial investigates whether two medications, anakinra and tocilizumab, can effectively treat NORSE, a rare brain condition causing continuous seizures in previously healthy individuals. These drugs are already used when standard treatments fail, but it remains unclear which works better or when to use them. Participants will either be randomly assigned to receive one of these drugs or be observed if randomization is not possible. Individuals who have recently experienced continuous seizures, have no underlying neurological conditions, and whose doctors are considering these medications as a treatment option might be eligible to join. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, you cannot use TNF blocking agents while participating. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that both anakinra and tocilizumab are generally safe, each with specific safety profiles. Anakinra has lowered seizure frequency in some patients, though not all become seizure-free. Studies report that patients tolerated the drug well, with no major side effects during long-term use.
For tocilizumab, research indicates it can help children with certain seizure conditions regain consciousness. One study showed it stopped seizures in six out of seven patients within three days. While individual results can vary, these findings suggest the drug is usually well-tolerated.
Both medications are already used to treat other conditions, supporting their safety. However, patients should always consult their healthcare provider about potential risks and benefits before starting any new treatment.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for status epilepticus because they each target inflammation in unique ways. Anakinra is distinct because it blocks the interleukin-1 receptor, potentially reducing brain inflammation more directly and quickly than traditional anti-seizure medications. Tocilizumab, on the other hand, inhibits the interleukin-6 receptor, offering a different approach to dampening the immune response that can exacerbate seizures. These targeted immunotherapies are promising because they might work faster and more effectively in managing seizures compared to the usual treatments, which often focus on controlling symptoms rather than addressing underlying inflammation.
What evidence suggests that this trial's treatments could be effective for NORSE?
This trial will compare Anakinra with Tocilizumab for treating status epilepticus. Research has shown that both Anakinra and Tocilizumab may help treat conditions like NORSE, which causes ongoing seizures. Participants may receive Anakinra, which studies have found can reduce seizure frequency and lead to noticeable improvements, although the long-term effects remain uncertain. Some patients experienced a significant drop in seizures soon after starting the treatment. Alternatively, participants may receive Tocilizumab, which has also been effective in stopping seizures and improving patient outcomes, with some reports of seizures stopping completely. Patients using Tocilizumab also experienced a significant decrease in seizure severity. While both treatments offer hope, more research is needed to better understand their effectiveness for this challenging condition.12346
Who Is on the Research Team?
Lawrence Hirsch, MD
Principal Investigator
Yale University
Are You a Good Fit for This Trial?
This trial is for children and adults with a severe brain condition called NORSE, which causes ongoing seizures that don't stop with usual treatments. Participants must be within the first 7 days of illness and their doctors were already considering using anakinra or tocilizumab.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either anakinra or tocilizumab within the first 7 days of their illness
Follow-up
Participants are monitored for safety and effectiveness after treatment, including medical evaluations and surveys
Long-term follow-up
Some participants may be followed annually beyond one year
What Are the Treatments Tested in This Trial?
Interventions
- Anakinra
- Tocilizumab
Trial Overview
The study compares two drugs, anakinra and tocilizumab, to see which is more effective in treating NORSE. Patients are randomly assigned to one of the drugs if eligible or observed for treatment timing effects if they can't be randomized.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
An observational cohort enrolling patients with acute cryptogenic NORSE who cannot be randomized or who are identified too late to be randomized by the end of day 7 .
A randomized controlled cohort (RCT) of anakinra vs. tocilizumab (targeted immunotherapies) started up to and including 7 days after the onset of status epilepticus (SE)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Citations
The Beneficial Outcome of Subsequent Treatment with ...
Upon starting anakinra in the chronic phase, seizures were reduced to four per day without any subsequent exacerbations. This suggests that ...
Anakinra and tocilizumab in the chronic phase of febrile ...
Median treatment duration was 9months (IQR: 7–20). While no patients became seizure-free, 20–50% reduction in seizure frequency was reported in 3/5 patients ...
Response to anakinra in new-onset refractory status ...
At day 28, anakinra at 5mg/kg every 12 hours was started, which resulted in notable clinical and EEG improvements, without SE recurrence after ...
4.
practicalneurology.com
practicalneurology.com/diseases-diagnoses/epilepsy-seizures/immunotherapy-for-management-of-refractory-and-super-refractory-status-epilepticus/39948/Immunotherapy for Refractory Status Epilepticus
The overall impact of anakinra on long-term outcomes remains unclear given the lack of controlled trials. ... efficacy data are highly variable.
Long-term neuropsychological outcomes in children with ...
These findings are concordant with data supporting that super-refractory status epilepticus causes worse neurological outcomes and lower rates of return to ...
Anakinra and tocilizumab in the chronic phase of febrile ...
Conclusion: This study provides promising data on effectiveness/safety of anakinra and tocilizumab in the chronic phase of FIRES. These ...
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