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

NCT ID: NCT05346666

Last Updated: 2022-11-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-25
• Study Completion Date: 2023-10-20

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Control Group

Group 1 received the conventional treatment for Status Epilepticus including propofol (loading dose is 3 to 5 mg/kg with maintenance of 1 to 15 mg/kg/h), phenobarbital (initial loading dose is 5 to 15 mg/kg over 1 hour. Infusion rates can be maintained at 0.5 to 15 mg/kg/h), and midazolam (a loading dose of 0.2 mg/kg is given with maintenance doses ranging between 0.05 and 2.0 mg/kg/h).

Group Type: ACTIVE_COMPARATOR

Tocilizumab Prefilled Syringe [Actemra]. propofole, phenobarbital, midazolam

Intervention Type: DRUG

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

Tocilizumab Group

Group 2 received the same treatment in group 1 in addition to tocilizumab that was initiated at a dose of 4mg/kg administered twice monthly with 1-week intervals for 3 months. A monthly dose (8mg/kg) of tocilizumab was added if needed.

Group Type: EXPERIMENTAL

Tocilizumab Prefilled Syringe [Actemra]. propofole, phenobarbital, midazolam

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: collaborator

Principal Investigator Mohanad Omar Ahmed, Msc Pharmacy Practice Department- Horus University

UNKNOWN

Sponsor Role: collaborator

Damanhour University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tanta University Hospital

Tanta, , Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Mohamed Hantirah, Prof.

Role: primary

dean@med.tanta.edu.eg

0020403407734

Other Identifiers

34233/11/20

Identifier Type: -

Identifier Source: org_study_id