Epilepsy in ChildrenNCT04219930
Nucleotide Protein -3 in Epileptic Children
An observational study of Epilepsy in Children, run by Assiut University.
Trial summary
Epilepsy is one of common serious neurological malfunction, characterized by recurrent unprovoked seizures. It always accompanied with multitude of complications as cognitive, behavioral, and psychiatric disorders. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Epilepsy in Children
- What is being tested?
- Expression of nucleotide protein -3
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2020to 1 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- Child
Study population: Epileptic children
Who may be able to join
- Epileptic children in Assiut university hospital, pediatric department, neurology unit.
Who cannot join
- Children with other chronic disease such as liver, kidney or heart disease
- patient who have apparent infection
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Biochemical Role of Nucleotide Protein -3 That Activate the Interleukin-1B in Epileptic Children
Epilepsy is one of common serious neurological malfunction, characterized by recurrent unprovoked seizures. It always accompanied with multitude of complications as cognitive, behavioral, and psychiatric disorders.
Experimental studies and clinical evidence obtained in animal models of epilepsy and human brain specimen from various drug-resistant forms of epilepsy show the activation of the innate and adaptive immunity mechanisms and the induction of the associated inflammatory processes in the epileptogenic foci.
Read the detailed description
Epilepsy affects approximately 1% of the world population. Lifetime prevalence of childhood and adolescence epilepsy (children <18 years) in Upper Egypt was 9.7/1000, with higher prevalence among children <12 years (10.8/1000).
There is a clear cause for epilepsy in only a minority of the cases, while in up to70% of all case of epilepsy in adults and children, no cause can be discovered. Some of the main causes of epilepsy include: Low oxygen during birth, head injuries that occur during birth or from accidents during youth or adulthood, brain tumors, infections such as meningitis or encephalitis, stroke or any other type of damage to the brain.
A role of inflammatory molecules in the generation of seizures had been first investigated when selected anti-inflammatory treatments, in particular, steroids, immuno-globulins, and adrenocorticotropic hormone (ACTH), were shown to control seizures in pediatric epilepsies refractory to conventional anticonvulsive drugs. In addition, specific epileptic disorders have been associated with the presence of neuronal antigen-directed antibodies in plasma or cerebrospinal fluid (CSF).
A nucleotide-binding oligomerization domains (NODs) are cytosolic proteins that include key regulators of apoptosis and pathogen resistance in mammals and plants. A large number of NODs contain leucine-rich repeats (LRRs), hence referred to as NOD-LRR proteins. The NLRP3 gene provides instructions for making a protein called cryopyrin. Cryopyrin is a member of a family of proteins called nucleotide-binding domain and leucine-rich repeat containing (NLR) proteins. NLR family have two common features: the first is a nucleotide-binding oligomerization domain which is bound by ribonucleotide-phosphates (rNTP) and is important for self-oligomerization. The second is a C-terminal leucine-rich repeat, which serves as a ligand-recognition domain for other receptors (e.g. Toll like receptor (TLR)) or microbial ligands, while NLRP3 has been identified in microglial cells.
- Conditions
- Epilepsy in Children
- Being tested
- Expression of nucleotide protein -3
- Keywords
- Epilepsy, Children, NLRP3, Interleukin B1, Nuclear Factor-Kappa B
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expression of nucleotide protein -3Diagnostic test
Expression of nucleotide protein -3 will be measured in serum by ELISA
| Study group | Role | What they receive |
|---|---|---|
| epileptic children | fifty patient with epilepsy Receives: Diagnostic Test: Expression of nucleotide protein -3 | |
| Healthy controls | thirty healthy control Receives: Diagnostic Test: Expression of nucleotide protein -3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean difference of nucleotide protein -3 inflammatory marker expression in epileptic children and controls
better understanding the role of inflammation in pathogenesis of epilepsy in children
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start1 Feb 2020 (estimated)
- Primary completion1 Nov 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Epilepsy in ChildrenStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham I El-mahdy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04219930
- Sponsor's protocol ID
- Epilepsy
- Status last verified
- Jan 2020
- First submitted
- 3 Jan 2020
- Last updated
- 9 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
He Q, Jiang L, Man S, Wu L, Hu Y, Chen W. Curcumin Reduces Neuronal Loss and Inhibits the NLRP3 Inflammasome Activation in an Epileptic Rat Model. Curr Neurovasc Res. 2018;15(3):186-192. doi: 10.2174/1567202615666180731100224.
PubMed 30062967Farghaly WM, Abd Elhamed MA, Hassan EM, Soliman WT, Yhia MA, Hamdy NA. Prevalence of childhood and adolescence epilepsy in Upper Egypt (desert areas). Egypt J Neurol Psychiatr Neurosurg. 2018;54(1):34. doi: 10.1186/s41983-018-0032-0. Epub 2018 Nov 9.
PubMed 30532513Xu D, Miller SD, Koh S. Immune mechanisms in epileptogenesis. Front Cell Neurosci. 2013 Nov 8;7:195. doi: 10.3389/fncel.2013.00195. eCollection 2013.
PubMed 24265605
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biochemical Role of Nucleotide Protein -3 That Activate the Interleukin-1B in Epileptic Children
- ClinicalTrials.gov ID
- NCT04219930
- Acronym / sponsor ID
- Epilepsy
- Conditions
- Epilepsy in Children
- Keywords
- Epilepsy, Children, NLRP3, Interleukin B1, Nuclear Factor-Kappa B
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (estimated)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 7 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Epilepsy is one of common serious neurological malfunction, characterized by recurrent unprovoked seizures. It always accompanied with multitude of complications as cognitive, behavioral, and psychiatric disorders.
Experimental studies and clinical evidence obtained in animal models of epilepsy and human brain specimen from various drug-resistant forms of epilepsy show the activation of the innate and adaptive immunity mechanisms and the induction of the associated inflammatory processes in the epileptogenic foci.
Detailed description
Epilepsy affects approximately 1% of the world population. Lifetime prevalence of childhood and adolescence epilepsy (children <18 years) in Upper Egypt was 9.7/1000, with higher prevalence among children <12 years (10.8/1000).
There is a clear cause for epilepsy in only a minority of the cases, while in up to70% of all case of epilepsy in adults and children, no cause can be discovered. Some of the main causes of epilepsy include: Low oxygen during birth, head injuries that occur during birth or from accidents during youth or adulthood, brain tumors, infections such as meningitis or encephalitis, stroke or any other type of damage to the brain.
A role of inflammatory molecules in the generation of seizures had been first investigated when selected anti-inflammatory treatments, in particular, steroids, immuno-globulins, and adrenocorticotropic hormone (ACTH), were shown to control seizures in pediatric epilepsies refractory to conventional anticonvulsive drugs. In addition, specific epileptic disorders have been associated with the presence of neuronal antigen-directed antibodies in plasma or cerebrospinal fluid (CSF).
A nucleotide-binding oligomerization domains (NODs) are cytosolic proteins that include key regulators of apoptosis and pathogen resistance in mammals and plants. A large number of NODs contain leucine-rich repeats (LRRs), hence referred to as NOD-LRR proteins. The NLRP3 gene provides instructions for making a protein called cryopyrin. Cryopyrin is a member of a family of proteins called nucleotide-binding domain and leucine-rich repeat containing (NLR) proteins. NLR family have two common features: the first is a nucleotide-binding oligomerization domain which is bound by ribonucleotide-phosphates (rNTP) and is important for self-oligomerization. The second is a C-terminal leucine-rich repeat, which serves as a ligand-recognition domain for other receptors (e.g. Toll like receptor (TLR)) or microbial ligands, while NLRP3 has been identified in microglial cells.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| epileptic children | – | Diagnostic Test: Expression of nucleotide protein -3fifty patient with epilepsy |
| Healthy controls | – | Diagnostic Test: Expression of nucleotide protein -3thirty healthy control |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- Epileptic children
Key inclusion criteria (1 listed)
- Epileptic children in Assiut university hospital, pediatric department, neurology unit.
Key exclusion criteria (2 listed)
- Children with other chronic disease such as liver, kidney or heart disease
- patient who have apparent infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expression of nucleotide protein -3Expression of nucleotide protein -3 will be measured in serum by ELISA | Diagnostic test | Healthy controls, epileptic children |
Primary outcome
The mean difference of nucleotide protein -3 inflammatory marker expression in epileptic children and controls
Time frame: Baseline
better understanding the role of inflammation in pathogenesis of epilepsy in children
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
- Background: PubMed 30062967He Q, Jiang L, Man S, Wu L, Hu Y, Chen W. Curcumin Reduces Neuronal Loss and Inhibits the NLRP3 Inflammasome Activation in an Epileptic Rat Model. Curr Neurovasc Res. 2018;15(3):186-192. doi: 10.2174/1567202615666180731100224.
- Background: PubMed 30532513Farghaly WM, Abd Elhamed MA, Hassan EM, Soliman WT, Yhia MA, Hamdy NA. Prevalence of childhood and adolescence epilepsy in Upper Egypt (desert areas). Egypt J Neurol Psychiatr Neurosurg. 2018;54(1):34. doi: 10.1186/s41983-018-0032-0. Epub 2018 Nov 9.
- Background: PubMed 24265605Xu D, Miller SD, Koh S. Immune mechanisms in epileptogenesis. Front Cell Neurosci. 2013 Nov 8;7:195. doi: 10.3389/fncel.2013.00195. eCollection 2013.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy in Children, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact reham elmahdy (+201002714637, reham.elmahdy@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean difference of nucleotide protein -3 inflammatory marker expression in epileptic children and controls (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04219930, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2020; AzTrials last refreshed its copy on 5 Nov 2026.