Epilepsy
Conditions
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.
Interventions
DRUGTocilizumab 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
Sponsors
Tanta University
Principal Investigator Mohanad Omar Ahmed, Msc Pharmacy Practice Department- Horus University
Damanhour University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
double-blind
Eligibility
Sex/Gender
ALL
Age
15 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in the level of inflammatory biomarkers (IL-6, TNF-alpha, IL-1β and NF-κB ) | 3 months |
Countries
Egypt
Outcome results
None listed