Epilepsy; SeizureNCT06278428
Genotype, Phenotype, and Disease Progression of Developmental Epileptic Encephalopathy With Onset Before 2 Years of Age
An observational study of Epilepsy; Seizure and Child Development, run by Number 2 Children's Hospital, Ho Chi Minh City at 2 sites in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 23 months
- Conditions the study is for
- Epilepsy; Seizure, Child Development, Gene Abnormality
- How many people
- 50 participants
- Where
- 2 sitesVietnam
- Study dates
- 27 Feb 2024to 1 Nov 2028
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 23 months
- All sexes
- No healthy volunteers
- Child
Study population: The study population was patients with severe, early-onset epilepsy, suspected of having a genetic etiology
Who may be able to join
- 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.
Who cannot join
- Patients were removed from the study when they were lost to follow-up at 6 months
- -
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam2 sites, 2 recruiting
- Recruiting
Children hospital number 2
Ho Chi Minh City, 700000
Thuy-Minh-Thu NGUYEN, MD, +84983966371, dr.thu.nguyen.neurology@gmail.com
- Recruiting
University of Medicine and Pharmacy at Ho Chi Minh city
Ho Chi Minh City
Thuy Minh Thu NGUYEN, MD, PhD, thunguyen@ump.edu.vn
Le Trung Hieu NGUYEN, MD, PhD, nguyenletrunghieu@ump.edu.vn
About this study
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?
Read the detailed description
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. In Vietnam, the incidence of epilepsy is approximately 40 per 100,000 per year. The incidence of the disease in children is higher than in adults. Among them, children under 2 years old are the group with the highest incidence of epilepsy, and at the same time, the most dangerous groups of epilepsy are also likely to start at these ages, such as West syndrome, Dravet syndrome, and Dravet syndrome. Ohtahara syndrome. These syndromes belong to the group of epileptic and developmental encephalopathies. This group of diseases can be caused by many causes, such as structural, metabolic, infectious, and genetic causes. However, in children and young people, genetic causes are more common.
Thanks to the development of biotechnology and genetics, medicine is now discovering more and more genes related to epilepsy syndromes that begin before 2 years of age, which helps choose treatment methods for the disease. causes of epilepsy such as using the keto diet in children with loss-of-function mutations in SLC2A1 or avoiding sodium channel blockers in children with Dravet syndrome due to loss-of-function mutations in SCN1A. In addition, children with epileptic and developmental encephalopathy due to genetic causes are also at higher risk of global developmental delay and autism spectrum disorders. Therefore, monitoring the progress of children with epileptic and developmental encephalopathy due to genetic causes plays an important role in early intervention, helping to improve disease prognosis.
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. In our country, there have been a number of studies on epileptic and developmental encephalopathy, as follows: A study conducted at Children's Hospital 2 showed the detection rate of gene mutations in patients with epileptic encephalopathy. menstruation and development is 38%, mainly SCN1A genotype mutation and Dravet syndrome phenotype. Another study that followed the short-term course of epileptic and developmental encephalopathy patients on the keto diet found that the majority of Dravet syndrome patients responded well to this treatment. However, studies in our country only describe genotypes and phenotypes separately without including progression, or only monitor the progression of phenotypes with treatment methods without paying attention to genotypes, or do not focus on focuses on studying the group of epileptic and developmental encephalopathies with onset before 2 years of age, which is the group with the highest incidence and most danger. Furthermore, most studies are cross-sectional or only monitor short-term progress. Therefore, the question is what is the phenotype, genotype, and progression after 2 years of follow-up of children with epileptic and developmental encephalopathy with onset before 2 years of age? We want to conduct this study to answer the above question.
Researching this issue will make an important contribution to a better understanding of the genotype, phenotype, and course of epileptic and developmental encephalopathies, thereby aiding the treatment and management of the disease.
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| early onset developmental epileptic encephalopathy | Select one that meets all 5 of the following criteria: 1. Diagnosed with EIDEE or EIMFS or ISS or SMEI or EMAS (according to ILAE's diagnostic criteria 2022) 2. Diagnosed with drug-resistant epilepsy according to ILAE 2010 criteria (according to ILAE's diagnostic criteria 2010) 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genotye of early-onset developmental epileptic encephalopathy
Describing the genotype of early-onset developmental epileptic encephalopathy
Measured: 2/2024- 4/2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start27 Feb 2024
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy; SeizureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Number 2 Children's Hospital, Ho Chi Minh City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thuy-Minh-Thu NGUYEN, Number 2 Children's Hospital, Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06278428
- Sponsor's protocol ID
- DEE UMC
- Status last verified
- Jan 2025
- First submitted
- 19 Feb 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genotype, Phenotype, and Disease Progression of Developmental Epileptic Encephalopathy With Onset Before 2 Years of Age
- ClinicalTrials.gov ID
- NCT06278428
- Acronym / sponsor ID
- DEE UMC
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Number 2 Children's Hospital, Ho Chi Minh CityUniversity, hospital or other
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
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. In Vietnam, the incidence of epilepsy is approximately 40 per 100,000 per year. The incidence of the disease in children is higher than in adults. Among them, children under 2 years old are the group with the highest incidence of epilepsy, and at the same time, the most dangerous groups of epilepsy are also likely to start at these ages, such as West syndrome, Dravet syndrome, and Dravet syndrome. Ohtahara syndrome. These syndromes belong to the group of epileptic and developmental encephalopathies. This group of diseases can be caused by many causes, such as structural, metabolic, infectious, and genetic causes. However, in children and young people, genetic causes are more common.
Thanks to the development of biotechnology and genetics, medicine is now discovering more and more genes related to epilepsy syndromes that begin before 2 years of age, which helps choose treatment methods for the disease. causes of epilepsy such as using the keto diet in children with loss-of-function mutations in SLC2A1 or avoiding sodium channel blockers in children with Dravet syndrome due to loss-of-function mutations in SCN1A. In addition, children with epileptic and developmental encephalopathy due to genetic causes are also at higher risk of global developmental delay and autism spectrum disorders. Therefore, monitoring the progress of children with epileptic and developmental encephalopathy due to genetic causes plays an important role in early intervention, helping to improve disease prognosis.
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. In our country, there have been a number of studies on epileptic and developmental encephalopathy, as follows: A study conducted at Children's Hospital 2 showed the detection rate of gene mutations in patients with epileptic encephalopathy. menstruation and development is 38%, mainly SCN1A genotype mutation and Dravet syndrome phenotype. Another study that followed the short-term course of epileptic and developmental encephalopathy patients on the keto diet found that the majority of Dravet syndrome patients responded well to this treatment. However, studies in our country only describe genotypes and phenotypes separately without including progression, or only monitor the progression of phenotypes with treatment methods without paying attention to genotypes, or do not focus on focuses on studying the group of epileptic and developmental encephalopathies with onset before 2 years of age, which is the group with the highest incidence and most danger. Furthermore, most studies are cross-sectional or only monitor short-term progress. Therefore, the question is what is the phenotype, genotype, and progression after 2 years of follow-up of children with epileptic and developmental encephalopathy with onset before 2 years of age? We want to conduct this study to answer the above question.
Researching this issue will make an important contribution to a better understanding of the genotype, phenotype, and course of epileptic and developmental encephalopathies, thereby aiding the treatment and management of the disease.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| early onset developmental epileptic encephalopathy | – | –Select one that meets all 5 of the following criteria: 1. Diagnosed with EIDEE or EIMFS or ISS or SMEI or EMAS (according to ILAE's diagnostic criteria 2022) 2. Diagnosed with drug-resistant epilepsy according to ILAE 2010 criteria (according to ILAE's diagnostic criteria 2010) 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. |
Who may qualify
- Ages
- Up to 23 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population was patients with severe, early-onset epilepsy, suspected of having a genetic etiology
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients were removed from the study when they were lost to follow-up at 6 months
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Genotye of early-onset developmental epileptic encephalopathy
Time frame: 2/2024- 4/2025
Describing the genotype of early-onset developmental epileptic encephalopathy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy; Seizure and Child Development, run by Number 2 Children's Hospital, Ho Chi Minh City at 2 sites in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thuy-Minh-Thu Thuy Minh NGUYEN, MD (+84983966371, dr.thu.nguyen.neurology@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genotye of early-onset developmental epileptic encephalopathy (time frame: 2/2024- 4/2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.