NCT04219930

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 7, 2020

Completed
25 days until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 9, 2020

Status Verified

January 1, 2020

Enrollment Period

9 months

First QC Date

January 3, 2020

Last Update Submit

January 6, 2020

Conditions

Keywords

EpilepsyChildrenNLRP3Interleukin B1Nuclear Factor-Kappa B

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline

Study Arms (2)

epileptic children

fifty patient with epilepsy

Diagnostic Test: Expression of nucleotide protein -3

Healthy controls

thirty healthy control

Diagnostic Test: Expression of nucleotide protein -3

Interventions

Expression of nucleotide protein -3 will be measured in serum by ELISA

Healthy controlsepileptic children

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Epileptic children

You may qualify if:

  • Epileptic children in Assiut university hospital, pediatric department, neurology unit.

You may not qualify if:

  • Children with other chronic disease such as liver, kidney or heart disease
  • patient who have apparent infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 30062967BACKGROUND
  • Farghaly 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.

    PMID: 30532513BACKGROUND
  • Xu 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.

    PMID: 24265605BACKGROUND

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 3, 2020

First Posted

January 7, 2020

Study Start

February 1, 2020

Primary Completion

November 1, 2020

Study Completion

December 1, 2020

Last Updated

January 9, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share