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The Benefit and Safety of Older Generation Anti-Epileptic Drugs (AEDs) in Drug-Resistant Epilepsy Children

NCT05697614 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-01-26

No results posted yet for this study

Summary

The goal of this interventional study is to learn about the efficacy and safety of first line anti epileptic drugs (AEDs) as substitution therapy for children who are resistant to second-line AEDs. The main question to answer it aims are :

how much the difference proportion of responders (responders are children who achieve the decrease of seizure frequencies by 50%) how much time it is needed to achieve the decrease of seizure frequencies by 50% The patients who are eligible for the study and have given their consent, will be enrolled, divided into 2 groups, the control and intervention.

The participant should follow the 14 weeks of intervention that consists of 6 phases : baseline, initial dose, titration dose, maintenance dose, tapering-off dose, and new combination maintenance dose.

Conditions

  • Drug Resistant Epilepsy

Interventions

DRUG

Valproic acid

valproic acid is used for general epilepsy type, used in experimental group

DRUG

Carbamazepin

carbamazepine is used for focal type epilepsy, used in experimental group

DRUG

Phenytoin

phenytoin is used for both general or focal epilepsy in case valproic acid or carbamazepine is contraindicated, used in experimental group

DRUG

Lamotrigine

lamotrigine is used for general epilepsy type, used in control group

DRUG

Clobazam

clobazam is used for both general or focal epilepsy in case if lamotrigine or oxcarbazepine is not possible to be administered and is used particularly in myoclonic jerk , used in control group

DRUG

Oxcarbazepine

oxcarbazepine is used for focal type epilepsy, used in control group

Sponsors & Collaborators

  • Dr Cipto Mangunkusumo General Hospital

    lead OTHER

Principal Investigators

  • Roro Rukmi Windi Perdani Pediatrician · Cipto Mangunkusumo Hopsital - Medical Faculty of Indonesia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2023-05-30
Completion
2023-06-30

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05697614 on ClinicalTrials.gov