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NCT05740423 Clinical Trial

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

Epilepsy Clinical Trial

— ADORE  

Official title:
Anti-Seizure Medications Withdrawals After 2 Years of Seizure Remission

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05740423
Other study ID # HC20C0164
Secondary ID HC20C0164
Status Recruiting
Phase
First received
Last updated
Start date August 30, 2021
Est. completion date December 31, 2024

Study information
Verified date February 2023
Source Asan Medical Center
Contact Min-Jee Kim
Phone 821045204711
Email pradoxwh@naver.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1200
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Asan Medical Center Seoul

Sponsors (3)
Lead Sponsor Collaborator
Asan Medical Center Korea Health Industry Development Institute, Ministry of Health, Republic of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Patients umber of seizure recurrence Patients umber of seizure recurrence Up to 2 years
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