Possible Immuno-Modulatory Effect of Tocilizumab in Patients With Refractory Status Epilepticus.
Epilepsy
About this trial
This is an interventional treatment trial for Epilepsy
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.
Sites / Locations
- Tanta University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Control Group
Tocilizumab 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 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.