NCT05346666

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Damanhour University · Academic / Other
• Sex: All
• Age: 15 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	Tocilizumab Prefilled Syringe [Actemra]. propofole, phenobarbital, midazolam	Tocilizumab is an immuno-modulatory drug which act as interleukin (IL)-6 receptor inhibitor that blocks IL-6-mediated signal transduction. This drug is known to improve various diseases

Timeline

• Start date: 2022-06-25
• Primary completion: 2023-09-20
• Completion: 2023-10-20
• First posted: 2022-04-26
• Last updated: 2022-11-15

Locations

1 site across 1 country: Egypt