Predictors of Drug Resistant Epilepsy Among Pediatric Patients

NCT07241754 | Not Yet Recruiting

• 1 other identifier: Drugs resistant epilepsy
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.This study aims to determine the main predictors of drug resistance in pediatric epilepsy by examining clinical data, EEG abnormalities, and neuroimaging results, in order to support early identification of resistant cases and improve treatment strategies .
2. 2.Early introduction of new lines of treatment in case of refractory epilepsy as : Ketogenic diet , Rituximab and solumedrol

Conditions

Epilepsy; Seizure; Resistance

Outcome Measures

Primary Outcomes (1)

• Predictors of Drug Resistance in Pediatric Epilepsy

  Identification of clinical, EEG, and neuroimaging predictors of resistance to anti-seizure medications in pediatric epilepsy, to enable early recognition and guide treatment strategies.

  through 12 months of follow-up.

Secondary Outcomes (1)

• Assessed from the time of diagnosis of drug resistance up to 12 months following initiation of the alternative treatment.

  Assessed from the time of diagnosis of drug resistance up to 6 to 12 months following initiation of the alternative treatment.

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study will include children and adolescents aged 1 month to 18 years with a confirmed diagnosis of epilepsy according to ILAE criteria, who are followed at pediatric neurology clinics and epilepsy units. Eligible participants must have received antiepileptic drug therapy for at least 6 months and have available clinical records, EEG findings, and neuroimaging results. Patients with only acute symptomatic seizures, progressive neurodegenerative diseases, prior epilepsy surgery, or incomplete data will be excluded. Participants will be recruited consecutively from outpatient and inpatient services, with informed consent obtained from caregivers and assent from older children when appropriate.

You may qualify if:

• Children aged 1-18 years with a confirmed diagnosis of epilepsy.
• Both males and females will be included.

You may not qualify if:

• Children younger than 1 year or older than 18 years.
• Patients with acute symptomatic seizures (e.g., febrile seizures, metabolic or infectious causes) or pseudo refractory epilepsy (e .g. syncope or uncorrect ASMs)
• Patients controlled on antiseizure medications
• Refusal of parents or guardians to participate in the study

Sponsors & Collaborators

• Assiut University: lead

Related Publications (6)

• Loscher W, Potschka H, Sisodiya SM, Vezzani A. Drug Resistance in Epilepsy: Clinical Impact, Potential Mechanisms, and New Innovative Treatment Options. Pharmacol Rev. 2020 Jul;72(3):606-638. doi: 10.1124/pr.120.019539.

  PMID: 32540959 RESULT

• Devinsky O, Vezzani A, O'Brien TJ, Jette N, Scheffer IE, de Curtis M, Perucca P. Epilepsy. Nat Rev Dis Primers. 2018 May 3;4:18024. doi: 10.1038/nrdp.2018.24.

  PMID: 29722352 RESULT

• Sillanpaa M, Schmidt D. Natural history of treated childhood-onset epilepsy: prospective, long-term population-based study. Brain. 2006 Mar;129(Pt 3):617-24. doi: 10.1093/brain/awh726. Epub 2006 Jan 9.

  PMID: 16401617 RESULT

• Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000 Feb 3;342(5):314-9. doi: 10.1056/NEJM200002033420503.

  PMID: 10660394 RESULT

• Aaberg KM, Gunnes N, Bakken IJ, Lund Soraas C, Berntsen A, Magnus P, Lossius MI, Stoltenberg C, Chin R, Suren P. Incidence and Prevalence of Childhood Epilepsy: A Nationwide Cohort Study. Pediatrics. 2017 May;139(5):e20163908. doi: 10.1542/peds.2016-3908. Epub 2017 Apr 5.

  PMID: 28557750 RESULT

• Russ SA, Larson K, Halfon N. A national profile of childhood epilepsy and seizure disorder. Pediatrics. 2012 Feb;129(2):256-64. doi: 10.1542/peds.2010-1371. Epub 2012 Jan 23.

  PMID: 22271699 RESULT

MeSH Terms

Conditions

Epilepsy; Seizures

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dalia Abdelrahim Fakhry, Principal Investigator

CONTACT

+201126915064; Dalia.17289777@med.aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: December 29, 2025
• Primary Completion (Estimated): December 29, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-10