NCT06278428 Genotype, Phenotype, and Disease Progression of Developmental Epileptic Encephalopathy With Onset Before 2 Years of Age
| NCT ID | NCT06278428 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Number 2 Children's Hospital, Ho Chi Minh City |
| Condition | Epilepsy; Seizure |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-02-27 |
| Primary Completion | 2028-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2024-02-27 with a primary completion date of 2028-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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?
Eligibility 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 \-
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06278428 clinical trial?
This trial is open to participants of all sexes, up to 23 Months, studying Epilepsy; Seizure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06278428 currently recruiting?
Yes, NCT06278428 is actively recruiting participants. Contact the research team at dr.thu.nguyen.neurology@gmail.com for enrollment information.
Where is the NCT06278428 trial being conducted?
This trial is being conducted at Ho Chi Minh City, Vietnam, Ho Chi Minh City, Vietnam.
Who is sponsoring the NCT06278428 clinical trial?
NCT06278428 is sponsored by Number 2 Children's Hospital, Ho Chi Minh City. The trial plans to enroll 50 participants.
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