Predictors of Drug Resistant Epilepsy Among Pediatric Patients
NCT ID: NCT07241754
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
200 participants
OBSERVATIONAL
2025-12-29
2027-02-01
Brief Summary
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2. Early introduction of new lines of treatment in case of refractory epilepsy as : Ketogenic diet , Rituximab and solumedrol
Detailed Description
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Despite the remarkable advances in pharmacological therapy, the cornerstone of epilepsy management remains antiseizure medications (ASMs). More than two-thirds of children with epilepsy achieve satisfactory seizure control with one or two appropriately chosen medications. However, a considerable proportion-estimated at 20-40%-develop drug-resistant epilepsy (DRE) . According to the International League Against Epilepsy (ILAE), DRE is defined as the failure to achieve sustained seizure freedom after adequate trials of at least two well-tolerated and appropriately selected ASMs, whether administered as monotherapy or in combination . Children with DRE are at a particularly high risk of poor neurocognitive outcomes, behavioral problems, injury, psychosocial difficulties, and even increased mortality .
Given the serious consequences of uncontrolled epilepsy, early identification of patients at risk for ASM resistance is of paramount importance. Predictors of drug resistance in pediatric epilepsy have been widely studied, although results vary across different populations and study designs. Factors frequently reported include early age at seizure onset, high initial seizure frequency, abnormal developmental history, specific electroencephalographic (EEG) abnormalities, structural brain lesions, identifiable genetic syndromes, and poor response to the first-line ASM . Recognition of these predictors can enable clinicians to stratify patients into risk categories, anticipate treatment challenges, and implement timely alternative interventions such as epilepsy surgery, ketogenic diet, or neuromodulation .
Moreover, exploring predictors of ASM resistance in children is not only clinically relevant, but also contributes to a better understanding of the pathophysiology of epilepsy and its heterogeneous nature. By delineating the factors that influence treatment outcomes, researchers and clinicians may be able to develop more targeted therapeutic strategies, improve prognostic counseling for families, and ultimately enhance the overall management of pediatric epilepsy .
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Both males and females will be included.
Exclusion Criteria
* 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
1 Year
18 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Dalia Abdelrahim Fakhry Hussein
Principal Investigator
Central Contacts
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References
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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.
Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000 Feb 3;342(5):314-9. doi: 10.1056/NEJM200002033420503.
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.
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.
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.
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.
Other Identifiers
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Drugs resistant epilepsy
Identifier Type: -
Identifier Source: org_study_id