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NCT Number: NCT07343609

Predictive Value of Seizure Frequency at Onset for Long-Term Seizure Control

Epilepsy is a chronic neurological disorder characterized by recurrent unprovoked seizures, and achieving long-term seizure control remains a major therapeutic goal. Early clinical features at diagnosis, particularly seizure frequency at onset and early response to antiseizure drugs (AEDs), may provide important prognostic information. Previous studies suggest that higher early seizure burden and poor initial response to AEDs are associated with unfavorable long-term outcomes; however, the predictive value of seizure frequency and number at onset remains insufficiently explored in contemporary cohorts.

This retrospective cohort study will be conducted at the Neurology Clinic of Assiut University Children's Hospital between February 2026 and January 2027. It will include patients with tractable and intractable newly diagnosed epilepsy. Data will be collected from clinical records and structured interviews, covering demographic characteristics, detailed seizure history (with emphasis on seizure frequency at onset), treatment details, early and long-term seizure control, adherence, and adverse effects. Neurological examination findings, EEG results, and neuroimaging data will be reviewed to support epilepsy classification and identify potential prognostic factors.

The primary outcome is to assess whether higher seizure frequency at onset is associated with poorer long-term seizure control. Statistical analysis will include descriptive statistics, comparative analyses between seizure-frequency groups, multivariate logistic regression to identify independent predictors, and ROC curve analysis to evaluate predictive accuracy. Ethical approval, informed consent, and data confidentiality will be ensured throughout the study.

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Key information

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients with tractable and intractable epilepsy.

Exclusion criteria

-

Treatment and study plan

observational study (no intervention)

Other

No intervention was applied. This is an observational study in which participants underwent routine clinical and radiological assessments only, with no experimental or therapeutic intervention.

Primary outcomes

  1. To assess whether higher seizure frequency at onset is associated with poorer long-term seizure control.

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 15, 2026
Registry last updated
Jan 15, 2026

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

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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.