NCT07343609

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
9mo left

Started Jan 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress31%
Jan 2026Jan 2027

First Submitted

Initial submission to the registry

January 7, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

January 10, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2027

Expected
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2027

Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

January 7, 2026

Last Update Submit

January 7, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

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

    12 months

Interventions

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with tractable and intractable epilepsy.

You may qualify if:

  • \- All patients with tractable and intractable epilepsy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postgraduate Researcher, Faculty of Medicine, Assiut University

Study Record Dates

First Submitted

January 7, 2026

First Posted

January 15, 2026

Study Start

January 10, 2026

Primary Completion (Estimated)

January 10, 2027

Study Completion (Estimated)

January 30, 2027

Last Updated

January 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share