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

NCT05346666 | Unknown Phase 3

• 1 other identifier: 34233/11/20
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• change in the level of inflammatory biomarkers (IL-6, TNF-alpha, IL-1β and NF-κB )

  3 months

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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).

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

Tocilizumab Group

EXPERIMENTAL

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.

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

Interventions

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

Control Group; Tocilizumab Group

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damanhour University: lead
• Tanta University: collaborator
• Principal Investigator Mohanad Omar Ahmed, Msc Pharmacy Practice Department- Horus University: collaborator

Study Sites (1)

Tanta University Hospital

Tanta, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Epilepsy

Interventions

Phenobarbital; Midazolam

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Barbiturates; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: April 26, 2022
• Study Start: June 25, 2022
• Primary Completion: September 20, 2023
• Study Completion: October 20, 2023
• Last Updated: November 15, 2022

Record last verified: 2022-02

Locations

EG (1)