Possible Immuno-Modulatory Effect of Tocilizumab in Patients With Refractory Status Epilepticus. (NCT05346666) | Clinical Trial Compass
UnknownPhase 3
Possible Immuno-Modulatory Effect of Tocilizumab in Patients With Refractory Status Epilepticus.
Egypt50 participantsStarted 2022-06-25
Plain-language summary
Recently, the pathogenesis of epilepsy is immuno-modulatory and neuro-inflammatory which is commonly activated in epileptogenic brain regions in humans and is clearly involved in animal models of epilepsy. Inflammatory mediators in the blood and molecular imaging of neuro-inflammation could provide diagnostic, prognostic, and predictive biomarkers for epilepsy, which will be instrumental for patient stratification in future clinical studies. Dysfunction of the blood-brain barrier (BBB) may be responsible for abnormal neuronal firing. Disruption of the BBB causes the leakage of serum protein and leucocyte invasion into the brain. These exogenous inflammatory mediators have the potential to lower seizure thresholds, which could alter channel sensitivity, neurotransmitter uptake or release, and glia-associated regulation of extracellular environments, such as potassium concentration.
Who can participate
Age range
15 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age: 15-75 years old.
* Gender: Male and female.
* Newly diagnosed refractory status epilepticus patients who are scheduled to receive anti-epileptic drugs.
* Patients with normal renal and hematological functions.
Exclusion Criteria:
* Old age \>75 years old.
* Pregnant or lactating females.
* Severe renal impairment when GFR\<30 ml/min.
* Hepatic patients ( not recommended with active hepatic disease or hepatic impairment specially when ALT or AST \>3 times ULN).
* Neutropenia when neutrophil count \<500 cells/mm3 due to increase the risk of infection.
* Thrombocytopenia when platelet count \< 50000 cells/mm3.
* Patients take Immunosuppressant drugs.
* Cancer patient who taking chemotherapy.
* Patients with a known hypersensitivity to any of the used drugs.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
change in the level of inflammatory biomarkers (IL-6, TNF-alpha, IL-1β and NF-κB )