Overview

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

Status:
Not yet recruiting
Trial end date:
2023-10-20
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Damanhour University
Treatments:
Midazolam
Phenobarbital
Criteria
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.