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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05346666
• Other study ID #: 34233/11/20
• Status: Recruiting
• Phase: Phase 3
• Start date: June 25, 2022
• Est. completion date: October 20, 2023

Study information

• Verified date: February 2022
• Source: Damanhour University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 20, 2023
• Est. primary completion date: September 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy
• Status Epilepticus

Intervention

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

Locations

Country	Name	City	State
Egypt	Tanta University Hospital	Tanta

Sponsors (4)

Lead Sponsor	Collaborator
Damanhour University	Principal Investigator Mohanad Omar Ahmed, Msc Pharmacy Practice Department- Horus University, Principal Investigator Sahar El-Haggar, Prof Clinical pharmacy Department- Tanta University, Principal Investigator Sahar Hegazy, Prof Clinical pharmacy Department- Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in the level of inflammatory biomarkers (IL-6, TNF-alpha, IL-1ß and NF-?B )		3 months