NCT05269901

Brief Summary

Epilepsy is one of the most common neurologic disorders seen in children, often characterized by recurring seizures. Nearly 10.5 million children worldwide are estimated to have active epilepsy. Children with epilepsy are more likely to have developmental health and developmental comorbidities such as depression, anxiety, attention deficit hyperactivity disorder, learning disabilities, and developmental delay compared to children without epilepsy. Status epilepticus (SE) is the most common life-threatening emergency neurological emergency in children and leads to hippocampal neuronal cell death. The animal model proved SE-induced neuronal cell death in hippocampal CA1 and CA3 regions. Classical drugs like carbamazepine or phenytoin often cause behavioral problems and side effects such as unsteady gait, depression, and irritability. In addition, classical medicine did not protect cognitive function and preferred to drive drug-resistant. Therefore, it is necessary to develop a novel therapy to treat epilepsy. Ferroptosis is a new type of cell death, usually accompanied by a large amount of iron accumulation and lipid peroxidation. It is widely accepted that glutamate-mediated neuronal hyperexcitation plays a causative role in eliciting seizures, and cystine/glutamate antiporter inhibition induces ferroptosis. Hence, investigators hypothesize GPX4 dependent ferroptosis pathway may play a key role in eliciting seizures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 20, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 8, 2022

Completed
Last Updated

April 15, 2022

Status Verified

February 1, 2022

Enrollment Period

10 months

First QC Date

February 23, 2022

Last Update Submit

April 8, 2022

Conditions

Keywords

school-aged childrenferroptosisepilepsyGPX4

Outcome Measures

Primary Outcomes (1)

  • Rt-qPCR

    Rt-qPCR allows the investigation of gene expression changes; investigators used primers as follow: GPX4 Forward: GAGGCAAGACCGAAGTAAACTAC GPX4 Reverse: CCGAACTGGTTACACGGGAA P53 Forward: AACTGCGGGACGAGACAGA P53 Reverse: AGCTTCAAGAGCGACAAGTTTT SLC7A11 Forward: TCTCCAAAGGAGGTTACCTGC SLC7A11 Reverse: AGACTCCCCTCAGTAAAGTGAC

    Participants' blood samples were collected when enrolled in this study, and the results of different relative mRNA expression (GPX4, SLC7A11, P53) on two groups would be reported through study completion, an average of 1 year.

Secondary Outcomes (1)

  • Western blot

    Participants' blood samples were collected when enrolled in this study, and the results of different relative protein expressions (GPX4, SLC7A11, TP53) on two groups would be reported through study completion, an average of 1 year.

Study Arms (2)

Seizures group

20 newly diagnosed untreated school-aged children from Jan 20, 2021 to Jan 1, 2022 in affiliated Hospital of Jiangnan University, department of pediatrics.

Genetic: SLC7A11, GPX4, P53

Healthy control group

20 age-matched healthy school-aged children from Jan 20, 2021 to Jan 1, 2022 in affiliated Hospital of Jiangnan University, department of pediatrics.

Genetic: SLC7A11, GPX4, P53

Interventions

Obtained patients or healthy controls peripheral blood , used Western blot and Rt-qPCR to investigate the possible difference between two groups

Healthy control groupSeizures group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

school-aged children who admitted to our hospital from Jan 20, 2021 to Jan 1, 2022

You may qualify if:

  • Aged between 6 and 12 years old
  • Newly diagnosed untreated epilepsy

You may not qualify if:

  • Treated with medicine or another therapy
  • Had history of cancer diseases
  • Had history of endocrine diseases
  • Healthy control group
  • \. Aged between 6 and 12 years old
  • Had history of epilepsy
  • Had history of cancer diseases
  • Had history of endocrine diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Hospital of JiangNan University, Department of Pediatrics

Wuxi, Jiangsu, 226600, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

school-aged children peripheral blood

MeSH Terms

Conditions

Epilepsy

Interventions

Phospholipid Hydroperoxide Glutathione PeroxidaseGenes, p53

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Glutathione PeroxidasePeroxidasesOxidoreductasesEnzymesEnzymes and CoenzymesSelenoproteinsProteinsAmino Acids, Peptides, and ProteinsGenes, Tumor SuppressorGenes, NeoplasmGenesGenome ComponentsGenomeGenetic StructuresGenetic PhenomenaGenes, Recessive

Study Officials

  • YueYing Liu

    Affiliated Hospital of JiangNan University, department of pediatrics

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2022

First Posted

March 8, 2022

Study Start

January 20, 2021

Primary Completion

November 15, 2021

Study Completion

January 1, 2022

Last Updated

April 15, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Ferroptosis is a new type of cell death, usually accompanied by a large amount of iron accumulation and lipid peroxidation. It is widely accepted that glutamate-mediated neuronal hyperexcitation plays a causative role in eliciting seizures, and cystine/glutamate antiporter inhibition induces ferroptosis. Hence, we hypothesis GPX4 dependent ferroptosis pathway may play a key role in eliciting seizures.

Locations