NCT05697614

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

The Efficacy and Safety of First-Line Anti-Epileptic Drugs (AEDs) as Substitution Therapy in Children Who Are Resistant to Second-Line AEDs

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Dr Cipto Mangunkusumo General Hospital · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Each phase of the study is described below In baseline phase, data such as demographic, clinical characteristic including seizure frequency, seizure type, seizure onset, medication history, family history of seizure, and also developmental stages, will be recorded from electronic medical record. Besides, the CT-scan or MRI are also collected from the same source. After that, their quality of life will be assessed by QOLCE-55 validated questionnaire through self-guided report. Furthermore, the laboratory investigation and EEG will be performed. The next phase is intervention phase, started from initial phase and ended by the maintenance of new combination therapy phase, takes with overall 12 weeks. Initially, the substitution drugs with each initial dose are consumed. The drugs consist of valproic acid for the generalized and carbamazepine for focal epilepsies. On the other hand, the control group will take lamotrigine or clobazam for generalized and oxcarbazepine for focal ones. The phase continuous to titration dose, in which, the dose is raised gradually until it causes 50% of seizure reduction, and the next step is maintained the dose for about 2 weeks. \- The following is tapering-off and after that stopping the substituted drug, levetiracetam or topiramate, which is determined by considering individual condition. Yet, if the seizures increase more than one and a half time of the previous frequency during the phases, the intervention will be ended immediately. On the contrary, if the condition is better, then the children go to the maintenance of new combination, that is the substitution drug and the old drugs in which the seizures do not go up or even better keep going down.

Conditions

• Drug Resistant Epilepsy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-03-01
• Primary completion: 2023-05-30
• Completion: 2023-06-30
• First posted: 2023-01-26
• Last updated: 2023-01-26

Locations

3 sites across 1 country: Indonesia