Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-25 @ 5:09 AM
NCT ID:
NCT07281027
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Study:
NCT07281027
Study Brief:
Protocol Section:
NCT07281027