drugset / Trial / NCT05346666

Possible Immuno-Modulatory Effect of Tocilizumab in Patients With Refractory Status Epilepticus.

NCT05346666

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2022-06-25
Primary completion
2023-09-20
Completion
2023-10-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Tocilizumab Monoclonal antibody 4 mg/kg
Subject Tocilizumab Monoclonal antibody 8 mg/kg
Background Midazolam Small molecule
Background Phenobarbital Unknown
Background Propofol Small molecule

Indications