Risk Factors for Drug-Resistant Epilepsy in Children

NCT07723287 | Suspended

• 1 other identifier: IRB-PNTU-2025-250510602
• Study Type: observational
• Target: 375
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Epilepsy; Epilepsy (Treatment Refractory)

Outcome Measures

Primary Outcomes (1)

• 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.

  Minimum 12 months after initiation of antiseizure medication

Secondary Outcomes (1)

• Time to drug-resistant epilepsy

  Up to 36 months

Study Arms (1)

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.

Other: No Intervention: Observational Cohort

Interventions

No Intervention: Observational Cohort OTHER

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.

Children with newly diagnosed epilepsy

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children diagnosed with epilepsy receiving care at Children's Hospital 1, Ho Chi Minh City, Vietnam.

You may qualify if:

• 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.

You may not qualify if:

• Poor treatment adherence.
• Insufficient baseline data.
• Lost to follow-up.
• Psychogenic nonepileptic seizures.
• Severe systemic illness interfering with antiseizure medication.
• Acute symptomatic seizures.

Sponsors & Collaborators

• Pham Ngoc Thach University of Medicine: lead

Study Sites (1)

Children's Hospital 1, Ho Chi Minh City, Vietnam

Ho Chi Minh City, Hồ Chí Minh, Vietnam

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 23, 2026
• Study Start: January 19, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)