Clinical trial Recruiting at 2 sites Observational Ages Any age to 23 Months

Understanding genetic and developmental factors in early-onset epilepsy

Official title: Genotype, Phenotype, and Disease Progression of Developmental Epileptic Encephalopathy With Onset Before 2 Years of Age

Run by Number 2 Children's Hospital, Ho Chi Minh City · NCT06278428 · Data updated 2026-11-12

This study is trying to find out how genetic and developmental factors affect young children with early-onset epilepsy to see how these factors influence their growth and learning over two years.

Quick facts

Study typeObservational
AgesAny age to 23 Months
SexAll
Enrollment50 (estimated)
SponsorNumber 2 Children's Hospital, Ho Chi Minh City
Academic / other
Locations2 sites (Ho Chi Minh City and 1 other locations)
StatusRecruiting
StartedFebruary 27, 2024
Main results expectedNovember 1, 2028
Study endsNovember 1, 2028
Registry record updatedJanuary 9, 2025
Trial IDNCT06278428 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are children aged 0 to 23 months diagnosed with specific types of drug-resistant epilepsy.

Probably not a fit

Patients with a history of hypoxic, inflammatory, or traumatic encephalopathy may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate the genotype, phenotype, and disease progression of children diagnosed with developmental epileptic encephalopathy who are under 2 years of age. It focuses on identifying genetic causes of epilepsy and their correlation with developmental outcomes, including intellectual disabilities and autism spectrum disorders. The study will follow participants for two years to assess how these factors influence the progression of their condition. The research is particularly significant as it addresses a gap in knowledge regarding early-onset epilepsy in Vietnam.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and management of early-onset epilepsy, potentially guiding personalized treatment strategies.

How similar studies have gone: While there is limited research specifically in Vietnam, similar studies globally have shown promising results in understanding genetic factors in early-onset epilepsy.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Diagnosed with Early infantile developmental and epileptic encephalopathy or Epilepsy of infancy with migrating focal seizures or infantile spasms syndrome or severe myoclonic epilepsy of infancy or Epilepsy with myoclonic-atonic seizures
2. Diagnosed with drug-resistant epilepsy according to ILAE 2010 criteria
3. Age at the start of participating in the study ranged from 0 to 23 months old
4. Relatives agree to participate in the research
5. There is no medical history of any diagnosis of hypoxic encephalopathy or inflammatory encephalopathy or traumatic encephalopathy or cerebral infarction or cerebral hemorrhage.

Exclusion Criteria:

Patients were removed from the study when they were lost to follow-up at 6 months

\-

Where it's running

  • Children hospital number 2
    Ho Chi Minh City, Vietnam
    Recruiting
  • University of Medicine and Pharmacy at Ho Chi Minh city
    Ho Chi Minh City, Vietnam
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.