Newly Diagnosed Epilepsy With Focus on Seizure Frequency at Onset and Long-term Seizure ControlNCT07343609
Predictive Value of Seizure Frequency at Onset for Long-Term Seizure Control
An observational study of Newly Diagnosed Epilepsy With Focus on Seizure Frequency at Onset and Long-term Seizure Control, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Newly Diagnosed Epilepsy With Focus on Seizure Frequency at Onset and Long-term Seizure Control
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2026to 30 Jan 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with tractable and intractable epilepsy.
Who may be able to join
- All patients with tractable and intractable epilepsy.
Who cannot join
- -
About this study
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.
- Conditions
- Newly Diagnosed Epilepsy With Focus on Seizure Frequency at Onset and Long-term Seizure Control
- Being tested
- observational study (no intervention)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess whether higher seizure frequency at onset is associated with poorer long-term seizure control.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start10 Jan 2026 (estimated)
- Primary completion10 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newly Diagnosed Epilepsy With Focus on Seizure Frequency at Onset and Long-term Seizure ControlStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Farag Okaily, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07343609
- Sponsor's protocol ID
- Amira Farag
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 15 Jan 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Seizure Frequency at Onset for Long-Term Seizure Control
- ClinicalTrials.gov ID
- NCT07343609
- Acronym / sponsor ID
- Amira Farag
- Conditions
- Newly Diagnosed Epilepsy With Focus on Seizure Frequency at Onset and Long-term Seizure Control
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Jan 2026 (estimated)
- Primary completion
- 10 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 12 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with tractable and intractable epilepsy.
Key inclusion criteria (1 listed)
- All patients with tractable and intractable epilepsy.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational study (no intervention)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. | Other | – |
Primary outcome
To assess whether higher seizure frequency at onset is associated with poorer long-term seizure control.
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Newly Diagnosed Epilepsy With Focus on Seizure Frequency at Onset and Long-term Seizure Control, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess whether higher seizure frequency at onset is associated with poorer long-term seizure control. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.