Standardization of Anti-Seizure Medications Withdrawals A... | NCT05740423

Studies
Standardization of Anti-Seizure Medications Withdrawals After Seizure Remission in Young Patients With Epilepsy

NCT05740423

Sponsor

Asan Medical Center

Status

Unknown status

Last Update Posted

Feb 23, 2023Actual

Enrollment

1,200Estimated

Phase

Not provided

Conditions

Epilepsy
Epilepsy in Children

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
HC20C0164	Other Grant/Funding Number	Korea Health Industry Development Institute

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 30, 2021Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Jan 3, 2023

First Submission Date that Met QC Criteria

Feb 13, 2023

First Posted Date

Feb 23, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2023

Last Update Posted Date

Feb 23, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Min-Sun Yum, Professor, Asan Medical CenterPrincipal Investigator

Lead Sponsor

Asan Medical CenterOTHER

Collaborators

Name	Class
Ministry of Health, Republic of Korea	OTHER_GOV
Korea Health Industry Development Institute	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. Futhermore, we develop the scoring system for prediction of seizure recurrence to set the standard for safe withdrawal of ASM.

Detailed Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

24 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patients umber of seizure recurrence	Patients umber of seizure recurrence	Up to 2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with Epilepsy or acute provoked seizure according to the ILAE guideline
Patients with 2 years of seizure free periods

Exclusion Criteria:

Uncertain diagnosis of epilepsy or acute provoked seizure
Patients who do not want to participate in the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Patients with Epilepsy or acute provoked seizure according to the ILAE guideline

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Min-Jee Kim	Contact	821045204711		pradoxwh@naver.com
Min-Sun Yum	Contact	+82230103386		misun.yum@gmail.com

Overall Officials

Name	Affiliation	Role
Min-Sun Yum	Asan Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asan Medical Center	Recruiting	Seoul		05505	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D004827	Epilepsy

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided