NCT05555537

Brief Summary

Evaluation of the role of estimation of serum level of miRNAs223 and HMGB1in detection of patient with drug resistant epilepsy. Early detection of the prognosis might help in guiding patients for proper management and treatment strategy. This may open the door for new drug trials.

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
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2022

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

September 22, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 27, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

October 18, 2022

Status Verified

October 1, 2022

Enrollment Period

1.9 years

First QC Date

September 22, 2022

Last Update Submit

October 16, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • role of estimation of serum level of miRNAs223 and HMGB1in detection of patient with drug resistant epilepsy.

    Early detection of being drug resistant epilepsy might help in guiding patients for proper management and treatment strategy.

    2year

Study Arms (2)

Drug resistant epilepsy

failure to achieve sustained seizure freedom after adequate and well tolerated trials of two antiseizure medications

Diagnostic Test: MiRNA223 and High mobility group box1(HMGB1)

Medically controled epilepsy

seizure freedom for at least the last 6months) matched in sex and age.

Diagnostic Test: MiRNA223 and High mobility group box1(HMGB1)

Interventions

Measure tye 2 biomarkers miRNA223 and HMGB1 in drug resistant and in medically controled epilepsy

Drug resistant epilepsyMedically controled epilepsy

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Drug resistant epilepsy defined as(failure to achieve sustained seizure freedom after adequate and well tolerated trials of two anti-seizure medications) Well controlled epilepsy defined as(seizure freedom for at least the last 6months) matched in sex and age.

You may qualify if:

  • Patients diagnosed as drug resistant epilepsy .
  • Control group: patients diagnosed as medically controlled epilepsy

You may not qualify if:

  • Symptomatic epilepsy (vascular, tumor, post encephalitic, syndromic and febrile seizures).
  • Alzheimers disease
  • Parkinsons disease
  • amyotrophic lateral sclerosis
  • major depression disorder
  • Non neurological criteria: tumors and cardiovascular

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

EpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Safaa Ali Ali, Assistant lecture

CONTACT

Safaa Ali, Assistant

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecture

Study Record Dates

First Submitted

September 22, 2022

First Posted

September 27, 2022

Study Start

November 1, 2022

Primary Completion

October 1, 2024

Study Completion

November 1, 2024

Last Updated

October 18, 2022

Record last verified: 2022-10