EpilepsyPED-DRENCT07723287
Risk Factors for Drug-Resistant Epilepsy in Children
An observational study of Epilepsy and Epilepsy (Treatment Refractory), run by Pham Ngoc Thach University of Medicine at 1 site in Vietnam.
Trial summary
This prospective cohort study evaluates clinical, electroencephalographic predictors of drug-resistant epilepsy in children. Predictive statistical and machine-learning models will be developed to facilitate early identification of children at high risk for drug-resistant epilepsy. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Epilepsy, Epilepsy (Treatment Refractory)
- How many people
- 375 participants
- Where
- 1 siteVietnam
- Study dates
- 19 Jan 2026to 31 Dec 2028
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Up to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Children diagnosed with epilepsy receiving care at Children's Hospital 1, Ho Chi Minh City, Vietnam.
Who may be able to join
- Children younger than 16 years, including neonates.
- Diagnosed with epilepsy according to International League Against Epilepsy criteria.
- Receiving treatment or follow-up at Children's Hospital 1.
- Parent or legal guardian provides informed consent.
- Expected follow-up of at least 12 months.
Who cannot join
- Poor treatment adherence.
- Insufficient baseline data.
- Lost to follow-up.
- Psychogenic nonepileptic seizures.
- Severe systemic illness interfering with antiseizure medication.
- Acute symptomatic seizures.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Children's Hospital 1, Ho Chi Minh City, Vietnam
Ho Chi Minh City, Hồ Chí Minh
About this study
Official title: Risk Factors for Drug-Resistant Epilepsy in Children: A Prospective Cohort Study
This prospective cohort study evaluates clinical, electroencephalographic predictors of drug-resistant epilepsy in children. Predictive statistical and machine-learning models will be developed to facilitate early identification of children at high risk for drug-resistant epilepsy.
Read the detailed description
Epilepsy is one of the most common neurological disorders in childhood. Approximately one-third of pediatric patients eventually develop drug-resistant epilepsy despite appropriate antiseizure medication treatment. Early identification of children at high risk of drug resistance may facilitate timely referral for advanced therapies including epilepsy surgery, ketogenic diet, or neuromodulation.
This prospective cohort study aims to identify independent predictors of drug-resistant epilepsy in children treated at Children's Hospital 1, Ho Chi Minh City, Vietnam. Clinical characteristics, electroencephalography findings, neuroimaging, genetic testing, metabolic investigations, treatment response, and developmental outcomes will be prospectively collected.
Cox proportional hazards regression will be used to identify independent predictors of drug resistance. Machine learning models including logistic regression and random forest will subsequently be developed and internally validated to predict drug-resistant epilepsy.
- Conditions
- Epilepsy, Epilepsy (Treatment Refractory)
- Being tested
- No Intervention: Observational Cohort
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
Participants will receive standard clinical care as determined by their treating physicians. No intervention is assigned by the study protocol. The study is observational and does not influence treatment decisions.
| Study group | Role | What they receive |
|---|---|---|
| Children with newly diagnosed epilepsy | Children with newly diagnosed epilepsy enrolled in a prospective observational cohort and followed longitudinally to determine the development of drug-resistant epilepsy and identify predictors of drug resistance. Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of Drug-Resistant Epilepsy
Development of drug-resistant epilepsy according to the International League Against Epilepsy definition after failure of two appropriately selected and tolerated antiseizure medications.
Measured: Minimum 12 months after initiation of antiseizure medication
Secondary outcomes (1)
Time to drug-resistant epilepsy
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start19 Jan 2026
- Primary completion30 Sep 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Why it stopped: Study hasn't stopped yet
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 375 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pham Ngoc Thach University of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Tang, Pham Ngoc Thach University of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07723287
- Sponsor's protocol ID
- IRB-PNTU-2025-250510602
- Acronym
- PED-DRE
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Drug-Resistant Epilepsy in Children: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07723287
- Acronym / sponsor ID
- PED-DRE / IRB-PNTU-2025-250510602
- Conditions
- Epilepsy, Epilepsy (Treatment Refractory)
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Study hasn't stopped yet
- Enrolment
- 375 participants (estimated)
- Lead sponsor
- Pham Ngoc Thach University of MedicineUniversity, hospital or other
- Study start
- 19 Jan 2026 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 23 Jul 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.
This prospective cohort study evaluates clinical, electroencephalographic predictors of drug-resistant epilepsy in children. Predictive statistical and machine-learning models will be developed to facilitate early identification of children at high risk for drug-resistant epilepsy.
Detailed description
Epilepsy is one of the most common neurological disorders in childhood. Approximately one-third of pediatric patients eventually develop drug-resistant epilepsy despite appropriate antiseizure medication treatment. Early identification of children at high risk of drug resistance may facilitate timely referral for advanced therapies including epilepsy surgery, ketogenic diet, or neuromodulation.
This prospective cohort study aims to identify independent predictors of drug-resistant epilepsy in children treated at Children's Hospital 1, Ho Chi Minh City, Vietnam. Clinical characteristics, electroencephalography findings, neuroimaging, genetic testing, metabolic investigations, treatment response, and developmental outcomes will be prospectively collected.
Cox proportional hazards regression will be used to identify independent predictors of drug resistance. Machine learning models including logistic regression and random forest will subsequently be developed and internally validated to predict drug-resistant epilepsy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with newly diagnosed epilepsy | – | Other: No Intervention: Observational CohortChildren with newly diagnosed epilepsy enrolled in a prospective observational cohort and followed longitudinally to determine the development of drug-resistant epilepsy and identify predictors of drug resistance. |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children diagnosed with epilepsy receiving care at Children's Hospital 1, Ho Chi Minh City, Vietnam.
Key inclusion criteria (5 listed)
- Children younger than 16 years, including neonates.
- Diagnosed with epilepsy according to International League Against Epilepsy criteria.
- Receiving treatment or follow-up at Children's Hospital 1.
- Parent or legal guardian provides informed consent.
- Expected follow-up of at least 12 months.
Key exclusion criteria (6 listed)
- Poor treatment adherence.
- Insufficient baseline data.
- Lost to follow-up.
- Psychogenic nonepileptic seizures.
- Severe systemic illness interfering with antiseizure medication.
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 |
|---|---|---|
| No Intervention: Observational CohortParticipants will receive standard clinical care as determined by their treating physicians. No intervention is assigned by the study protocol. The study is observational and does not influence treatment decisions. | Other | Children with newly diagnosed epilepsy |
Primary outcome
Development of Drug-Resistant Epilepsy
Time frame: Minimum 12 months after initiation of antiseizure medication
Development of drug-resistant epilepsy according to the International League Against Epilepsy definition after failure of two appropriately selected and tolerated antiseizure medications.
1 secondary outcome
Time to drug-resistant epilepsy
Time frame: Up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Epilepsy and Epilepsy (Treatment Refractory), run by Pham Ngoc Thach University of Medicine at 1 site in Vietnam.
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 5 inclusion and 6 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: paused, as of the sponsor's last update on 23 Jul 2026. 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 Vietnam. 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?
Results are not available in the source record.
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?
Development of Drug-Resistant Epilepsy (time frame: Minimum 12 months after initiation of antiseizure medication). 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 23 Jul 2026.