Ignite Creation Date:
2024-05-06 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05697614
Status:
RECRUITING
Last Update Posted:
2023-01-26
First Post:
2022-11-28
Brief Title:
The Benefit and Safety of Older Generation Anti-Epileptic Drugs AEDs in Drug-Resistant Epilepsy Children
Sponsor:
Dr Cipto Mangunkusumo General Hospital
Organization:
Dr Cipto Mangunkusumo General Hospital
Study Overview
Official Title:
The Efficacy and Safety of First-Line Anti-Epileptic Drugs AEDs as Substitution Therapy in Children Who Are Resistant to Second-Line AEDs
Status:
RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None