EpilepsyADORENCT05740423
Standardization of Anti-Seizure Medications Withdrawals After Seizure Remission in Young Patients With Epilepsy
An observational study of Epilepsy and Epilepsy in Children, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The proper period of anti-seizure medication (ASM) treamtment is important for decreasing side effect of ASM and recurrence of seizure. We evaluate reliable risk factor analysis for safe withdrawal of ASM in children with epilepsy. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Epilepsy, Epilepsy in Children
- How many people
- 1,200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Aug 2021to 31 Dec 2024
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with Epilepsy or acute provoked seizure according to the ILAE guideline
Who may be able to join
- Patients with Epilepsy or acute provoked seizure according to the ILAE guideline
- Patients with 2 years of seizure free periods
Who cannot join
- Uncertain diagnosis of epilepsy or acute provoked seizure
- Patients who do not want to participate in the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, 05505
Min-Jee Kim, +821045204711, pradoxwh@naver.com
Min-Sun Yum, +82230103386, misun.yum@gmail.com
About this study
Official title: Anti-Seizure Medications Withdrawals After 2 Years of Seizure Remission
The proper period of anti-seizure medication (ASM) treamtment is important for decreasing side effect of ASM and recurrence of seizure. We evaluate reliable risk factor analysis for safe withdrawal of ASM in children with epilepsy. Futhermore, we develop the scoring system for prediction of seizure recurrence to set the standard for safe withdrawal of ASM.
Read the detailed description
The proper period of anti-seizure medication (ASM) treamtment is important for decreasing side effect of ASM and recurrence of seizure. We evaluate reliable risk factor analysis for safe withdrawal of ASM in children with epilepsy. Futhermore, we develop the scoring system for prediction of seizure recurrence to set the standard for safe withdrawal of ASM.
The enroll criteria as follow:
- patients with epilepsy or acute provoked seizure accroding to the ILAE definition
- patients who have been 2 years of seizure free with or without ASM
The patients with seizure recurrence during follow-up or end of follow-up period of 24 months will end this stutdy.
- Conditions
- Epilepsy, Epilepsy in Children
- Medical subject headings
- Epilepsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients umber of seizure recurrence
Patients umber of seizure recurrence
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start30 Aug 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Republic of Korea, Korea Health Industry Development Institute
- Responsible party
- Principal investigator, Min-Sun Yum, Asan Medical Center
- Investigators
- Min-Sun Yum, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05740423
- Sponsor's protocol ID
- HC20C0164
- Other IDs
- HC20C0164
- Acronym
- ADORE
- Status last verified
- Feb 2023
- First submitted
- 3 Jan 2023
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-Seizure Medications Withdrawals After 2 Years of Seizure Remission
- ClinicalTrials.gov ID
- NCT05740423
- Acronym / sponsor ID
- ADORE / HC20C0164
- Conditions
- Epilepsy, Epilepsy in Children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Ministry of Health, Republic of Korea, Korea Health Industry Development Institute
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 23 Feb 2023 (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.
The proper period of anti-seizure medication (ASM) treamtment is important for decreasing side effect of ASM and recurrence of seizure. We evaluate reliable risk factor analysis for safe withdrawal of ASM in children with epilepsy. Futhermore, we develop the scoring system for prediction of seizure recurrence to set the standard for safe withdrawal of ASM.
Detailed description
The proper period of anti-seizure medication (ASM) treamtment is important for decreasing side effect of ASM and recurrence of seizure. We evaluate reliable risk factor analysis for safe withdrawal of ASM in children with epilepsy. Futhermore, we develop the scoring system for prediction of seizure recurrence to set the standard for safe withdrawal of ASM.
The enroll criteria as follow:
- patients with epilepsy or acute provoked seizure accroding to the ILAE definition
- patients who have been 2 years of seizure free with or without ASM
The patients with seizure recurrence during follow-up or end of follow-up period of 24 months will end this stutdy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with Epilepsy or acute provoked seizure according to the ILAE guideline
Key inclusion criteria (2 listed)
- Patients with Epilepsy or acute provoked seizure according to the ILAE guideline
- Patients with 2 years of seizure free periods
Key exclusion criteria (2 listed)
- Uncertain diagnosis of epilepsy or acute provoked seizure
- Patients who do not want to participate in the study
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
Patients umber of seizure recurrence
Time frame: Up to 2 years
Patients umber of seizure recurrence
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
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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. This study is not recruiting at the moment.
Min-Sun Yum principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy and Epilepsy in Children, run by Asan Medical Center at 1 site in South Korea.
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 2 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: status not confirmed, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min-Jee Kim (821045204711, pradoxwh@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients umber of seizure recurrence (time frame: Up to 2 years). 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 23 Feb 2023.