Understanding genetic and developmental factors in early-onset epilepsy
Genotype, Phenotype, and Disease Progression of Developmental Epileptic Encephalopathy With Onset Before 2 Years of Age
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 type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | N/A to 23 Months |
| Sex | All |
| Sponsor | Number 2 Children's Hospital, Ho Chi Minh City Academic / other |
| Locations | 2 sites (Ho Chi Minh City and 1 other locations) |
| Trial ID | NCT06278428 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 0 to 23 months diagnosed with specific types of drug-resistant epilepsy.
Not a fit: Patients with a history of hypoxic, inflammatory, or traumatic encephalopathy may not benefit from this study.
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 performed: While there is limited research specifically in Vietnam, similar studies globally have shown promising results in understanding genetic factors in early-onset epilepsy.
Eligibility criteria
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 this trial is running
Ho Chi Minh City and 1 other locations
- 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
- Study coordinator: Thuy-Minh-Thu Thuy Minh NGUYEN, MD
- Email: dr.thu.nguyen.neurology@gmail.com
- Phone: +84983966371
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.