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

Primary Purpose

Epilepsy

Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Tocilizumab Prefilled Syringe [Actemra]. propofole, phenobarbital, midazolam
Sponsored by
Damanhour University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy

Eligibility Criteria

15 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Tocilizumab Group

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 24, 2022
Last Updated
November 10, 2022
Sponsor
Damanhour University
Collaborators
Principal Investigator Sahar El-Haggar, Prof Clinical pharmacy Department- Tanta University, Principal Investigator Mohanad Omar Ahmed, Msc Pharmacy Practice Department- Horus University, Principal Investigator Sahar Hegazy, Prof Clinical pharmacy Department- Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT05346666
Brief Title
Possible Immuno-Modulatory Effect of Tocilizumab in Patients With Refractory Status Epilepticus.
Official Title
Possible Immuno-Modulatory Effect of Tocilizumab in Patients With Refractory Status Epilepticus.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 25, 2022 (Actual)
Primary Completion Date
September 20, 2023 (Anticipated)
Study Completion Date
October 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damanhour University
Collaborators
Principal Investigator Sahar El-Haggar, Prof Clinical pharmacy Department- Tanta University, Principal Investigator Mohanad Omar Ahmed, Msc Pharmacy Practice Department- Horus University, Principal Investigator Sahar Hegazy, Prof Clinical pharmacy Department- Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
double-blind
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Tocilizumab Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tocilizumab Prefilled Syringe [Actemra]. propofole, phenobarbital, midazolam
Intervention Description
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
Primary Outcome Measure Information:
Title
change in the level of inflammatory biomarkers (IL-6, TNF-alpha, IL-1β and NF-κB )
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Tanta University Hospital
City
Tanta
ZIP/Postal Code
31527
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Hantirah, Prof.
Phone
0020403407734
Email
dean@med.tanta.edu.eg

12. IPD Sharing Statement

Learn more about this trial

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

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