Predictors of Anti-seizure Medication Resistance in Pediatric Epilepsy

Not yet recruiting

• Conditions: Epilepsy; Seizure; Resistance

• Registration Number: NCT07241754
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed Description

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 .

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-11-17
• Study First Submitted QC: 2025-11-17
• Last Update Submitted: 2025-11-17
• Study First Posted: 2025-11-21
• Last Update Posted: 2025-11-21
• Study Start: 2025-12-01
• Primary Completion: 2026-12-01
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Predictors of Drug Resistance in Pediatric Epilepsy	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 Outcome Measures

Name	Time	Method
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.	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.