- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients with tractable and intractable epilepsy.
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To assess whether higher seizure frequency at onset is associated with poorer long-term seizure control.
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Amira Farag
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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