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NCT Number: NCT07241754

Predictors of Drug Resistant Epilepsy Among Pediatric Patients

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. Early introduction of new lines of treatment in case of refractory epilepsy as : Ketogenic diet , Rituximab and solumedrol

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Key information

About this study

Epilepsy is among the most prevalent chronic neurological disorders in the pediatric population, affecting approximately 0.5-1% of children worldwide . It is characterized by recurrent, unprovoked seizures resulting from abnormal, excessive, or synchronous neuronal activity in the brain. Epilepsy in childhood represents a major public health concern, not only because of its relatively high incidence, but also due to its significant impact on neurodevelopment, cognitive functions, psychosocial well-being, and overall quality of life .

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Predictors of Drug Resistance in Pediatric Epilepsy

    Time frame: through 12 months of follow-up.

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

Secondary outcomes

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

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

    Evaluation of the role of introducing alternative treatment modalities (such as ketogenic diet, rituximab, and solumedrol) in pediatric patients who develop refractory epilepsy, and their impact on seizure control and clinical outcomes.

Study contacts

Contact information is provided by the study sponsor or research team.

Dalia Abdelrahim Fakhry, Principal Investigator

CONTACT

[email protected]

+201126915064

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Predictors of Anti-seizure Medication Resistance in Pediatric Epilepsy

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 21, 2025
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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