Drug Resistant EpilepsyNCT07275125
Outcomes of Drug Resistant Epileptic Pediatric Patient by Modified Atkins Diet
An observational study of Drug Resistant Epilepsy, run by Sohag University at 1 site in Egypt.
Trial summary
To assess clinical outcomes in drug resistant epileptic pediatric patient by modified atkin diet with focusing on following points: 1. Control of seizures(frequency , duration and numbers of hospital admissions) . 2. Quality of life by pediatric quality of life inventory v4. 3. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Drug Resistant Epilepsy
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Dec 2025to 30 Jun 2026
- 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 1 year to 18 years
- All sexes
- Child, Adult
Study population: This study will include pediatric patients with drug-resistant epilepsy (DRE) attending the ketogenic diet clinic at the Pediatric Neurology Unit, Sohag University Hospital. Eligible participants are children aged 1-18 years who meet the International League Against Epilepsy (ILAE) definition of DRE and have been on a ketogenic dietary therapy, specifically the Modified Atkins Diet (MAD), for at least 6 months.
Who may be able to join
- Children aged 1-18 years.
- Diagnosed with drug-resistant epilepsy according to ILAE definition.[2]
- On KD for at least 6 months.
Who cannot join
- - Patients with contraindicated metabolic/genetic conditions.
- Non-compliance with KD .
- Patients on alternative dietary therapies (e.g., low glycemic diet)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Sohag faculty of medicine
Sohag
Sohag faculty of medicine, 00201069770585, Mm.ss.elsayed227@gmail.com
About this study
To assess clinical outcomes in drug resistant epileptic pediatric patient by modified atkin diet with focusing on following points:
- Control of seizures(frequency , duration and numbers of hospital admissions) .
- Quality of life by pediatric quality of life inventory v4.
- Cognitive function by stanford binet intelligence scale 5th edition.
- Growth parameters ( weight, height will be combined to report BMI in kg/m^2).
- Conditions
- Drug Resistant Epilepsy
- Medical subject headings
- Drug Resistant Epilepsy
What is being measured
The primary outcome is the main question the study is designed to answer.
1-Control of seizures(frequency and duration of seizures) . 2-Quality of life by pediatric quality of life inventory v4. 3-Cognitive function by stanford binet intelligence scale 5th edition. 4-Growth parameters (weight and height by BMI in kg/m^2)
Measured: 6 month
Secondary outcomes (1)
to detect clinical predictors of seizures control ( frequency of attack and duration) in patients with drug resistant epilepsy using MAD.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start30 Dec 2025 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Resistant EpilepsyStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Saber Elsayed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07275125
- Sponsor's protocol ID
- Soh-med-25-9-IMS
- Status last verified
- Nov 2025
- First submitted
- 28 Sep 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Drug Resistant Epileptic Pediatric Patient by Modified Atkins Diet
- ClinicalTrials.gov ID
- NCT07275125
- Acronym / sponsor ID
- Soh-med-25-9-IMS
- Conditions
- Drug Resistant Epilepsy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 30 Dec 2025 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 10 Dec 2025 (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.
To assess clinical outcomes in drug resistant epileptic pediatric patient by modified atkin diet with focusing on following points:
- Control of seizures(frequency , duration and numbers of hospital admissions) .
- Quality of life by pediatric quality of life inventory v4.
- Cognitive function by stanford binet intelligence scale 5th edition.
- Growth parameters ( weight, height will be combined to report BMI in kg/m^2).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- This study will include pediatric patients with drug-resistant epilepsy (DRE) attending the ketogenic diet clinic at the Pediatric Neurology Unit, Sohag University Hospital. Eligible participants are children aged 1-18 years who meet the International League Against Epilepsy (ILAE) definition of DRE and have been on a ketogenic dietary therapy, specifically the Modified Atkins Diet (MAD), for at least 6 months.
Key inclusion criteria (3 listed)
- Children aged 1-18 years.
- Diagnosed with drug-resistant epilepsy according to ILAE definition.[2]
- On KD for at least 6 months.
Key exclusion criteria (3 listed)
- - Patients with contraindicated metabolic/genetic conditions.
- Non-compliance with KD .
- Patients on alternative dietary therapies (e.g., low glycemic diet)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
1-Control of seizures(frequency and duration of seizures) . 2-Quality of life by pediatric quality of life inventory v4. 3-Cognitive function by stanford binet intelligence scale 5th edition. 4-Growth parameters (weight and height by BMI in kg/m^2)
Time frame: 6 month
1 secondary outcome
to detect clinical predictors of seizures control ( frequency of attack and duration) in patients with drug resistant epilepsy using MAD.
Time frame: 6 month
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 10 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Resistant Epilepsy, run by Sohag University at 1 site in Egypt.
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 3 inclusion and 3 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 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Mahmoud Saber Elsayed (00201069770585, Mm.ss.elsayed277@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-Control of seizures(frequency and duration of seizures) . 2-Quality of life by pediatric quality of life inventory v4. 3-Cognitive function by stanford binet intelligence scale 5th edition. 4-Growth parameters (weight and height by BMI in kg/m^2) (time frame: 6 month). 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 10 Dec 2025.