Status:
UNKNOWN
Possible Immuno-Modulatory Effect of Tocilizumab in Patients With Refractory Status Epilepticus.
Lead Sponsor:
Damanhour University
Collaborating Sponsors:
Tanta University
Principal Investigator Mohanad Omar Ahmed, Msc Pharmacy Practice Department- Horus University
Conditions:
Epilepsy
Eligibility:
All Genders
15-75 years
Phase:
PHASE3
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 epil...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 20 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05346666
Start Date
June 25 2022
End Date
October 20 2023
Last Update
November 15 2022
Active Locations (1)
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1
Tanta University Hospital
Tanta, Egypt, 31527