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

Sponsor
Asan Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05740423
Collaborator
Ministry of Health, Republic of Korea (Other), Korea Health Industry Development Institute (Other)
1,200
Enrollment
1
Location
40
Anticipated Duration (Months)
30
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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:

    1. patients with epilepsy or acute provoked seizure accroding to the ILAE definition

    2. 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

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    1200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Anti-Seizure Medications Withdrawals After 2 Years of Seizure Remission
    Actual Study Start Date :
    Aug 30, 2021
    Anticipated Primary Completion Date :
    Dec 31, 2024
    Anticipated Study Completion Date :
    Dec 31, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Patients umber of seizure recurrence [Up to 2 years]

      Patients umber of seizure recurrence

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Asan Medical Center Seoul Korea, Republic of 05505

    Sponsors and Collaborators

    • Asan Medical Center
    • Ministry of Health, Republic of Korea
    • Korea Health Industry Development Institute

    Investigators

    • Principal Investigator: Min-Sun Yum, Asan Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Min-Sun Yum, Professor, Asan Medical Center
    ClinicalTrials.gov Identifier:
    NCT05740423
    Other Study ID Numbers:
    • HC20C0164
    • HC20C0164
    First Posted:
    Feb 23, 2023
    Last Update Posted:
    Feb 23, 2023
    Last Verified:
    Feb 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Epilepsy
    Seizures

    Study Results

    No Results Posted as of Feb 23, 2023