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NCT06278428Recruiting

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

Source: ClinicalTrials.gov · Last updated 9 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

According to estimates by the World Health Organization in 2019, more than 50 million people around the world have epilepsy. Nearly 80% of patients with epilepsy live in developing countries. Among them, children under 2 years old are the group with the highest incidence of epilepsy, and at the same time, the most dangerous epilepsy groups are also likely to start at these ages. World medical literature on epileptic encephalopathy and early-onset development before 2 years of age records that 71% of children have severe intellectual disability and 60% of children show signs of autism spectrum disorder, of which Children with epileptic and developmental encephalopathy due to genetic causes are at higher risk of developing neurodevelopmental disorders than children with epileptic and developmental encephalopathy due to other causes. However, in Vietnam, there is no research on this topic. The question is what are the phenotypes, genotypes, and progression after 2 years of follow-up of Vietnamese children with epileptic and developmental encephalopathy with onset before 2 years of age?

Status (registry)
Recruiting
Study type
Observational
Enrollment
50 (estimated)
First submitted
19 Feb 2024
Start date
27 Feb 2024
Primary completion date
1 Nov 2028
Lead sponsor
Number 2 Children's Hospital, Ho Chi Minh City
Diseases
Epilepsy
NCT number
NCT06278428

What you commit to

  • Study type: Observational
  • Planned participants: 50
  • From 27 Feb 2024 to the primary completion date, 1 Nov 2028
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

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

Who the study is looking for

  • 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
  • Diagnosed with drug-resistant epilepsy according to ILAE 2010 criteria
  • Age at the start of participating in the study ranged from 0 to 23 months old
  • Relatives agree to participate in the research
  • There is no medical history of any diagnosis of hypoxic encephalopathy or inflammatory encephalopathy or traumatic encephalopathy or cerebral infarction or cerebral hemorrhage.

Age in the registry: - to 23 months · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Medicine and Pharmacy at Ho Chi Minh City
Coordinator of this site? Confirm its status
Ho Chi Minh CityVietnamRecruiting
Children hospital number 2
Coordinator of this site? Confirm its status
Ho Chi Minh CityVietnamRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.