The Benefit and Safety of Older Generation Anti-Epileptic Drugs (AEDs) in Drug-Resistant Epilepsy Children
NCT ID: NCT05697614
Last Updated: 2023-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
100 participants
INTERVENTIONAL
2023-03-01
2023-06-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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intervention
valproic acid 15 - 60 mg/kg body weight/day, divided into 2 dosages/day for 12 weeks ; carbamazepine 10 - 30 mg/kg body weight/day, divided into 2 dosages/day for 12 weeks ; phenytoin 5-7 mg/kg body weight/day, divided into 2 dosages/day for 12 weeks
Valproic acid
valproic acid is used for general epilepsy type, used in experimental group
Carbamazepin
carbamazepine is used for focal type epilepsy, used in experimental group
Phenytoin
phenytoin is used for both general or focal epilepsy in case valproic acid or carbamazepine is contraindicated, used in experimental group
control
lamotrigine 0.2 mg/kg body weight/day, divided into 2 dosages/day for 12 weeks ; clobazam 0.1 - 0.8 body weight/day, divided into 2 dosages/day for 12 weeks ; oxcarbazepine10 - 30 mg/kg body weight/day, divided into 2 dosages/day for 12 weeks
Lamotrigine
lamotrigine is used for general epilepsy type, used in control group
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
Oxcarbazepine
oxcarbazepine is used for focal type epilepsy, used in control group
Interventions
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Valproic acid
valproic acid is used for general epilepsy type, used in experimental group
Carbamazepin
carbamazepine is used for focal type epilepsy, used in experimental group
Phenytoin
phenytoin is used for both general or focal epilepsy in case valproic acid or carbamazepine is contraindicated, used in experimental group
Lamotrigine
lamotrigine is used for general epilepsy type, used in control group
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
Oxcarbazepine
oxcarbazepine is used for focal type epilepsy, used in control group
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Children diagnosed as drug-resistant epilepsy by pediatric neurologists, diagnosis was based on the ILAE 2017 criteria
3. Children will have got at least 3 months of combination therapy that consists of levetiracetam of topiramate with optimal dosage but haven't got seizure reduction
Exclusion Criteria
2. Suffered from status epilepticus in the prior 3 months before the study begins Past medical history of idiosyncrasies or severe adverse drug reactions caused by the
3. substitution therapy that will be given
1 Year
18 Years
ALL
No
Sponsors
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Dr Cipto Mangunkusumo General Hospital
OTHER
Responsible Party
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Roro Rukmi Windi Perdani
Principal investigator
Principal Investigators
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Roro Rukmi Windi Perdani Pediatrician
Role: PRINCIPAL_INVESTIGATOR
Cipto Mangunkusumo Hopsital - Medical Faculty of Indonesia University
Locations
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Cipto Mangunkusumo Hospital
Jakarta Pusat, Jakarta Special Capital Region, Indonesia
Harapan Kita Hospital
Jakarta, , Indonesia
Fatmawati Hospital
Jakarta, , Indonesia
Countries
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Central Contacts
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Facility Contacts
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R. Anna Tjandrajani
Role: primary
Deddy Ria
Role: primary
References
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Perdani RRW, Arozal W, Mangunatmadja I, Kaswandani N, Handryastuti S, Medise BE, Hardi H, Thandavarayan RA, Oswari H. The efficacy and safety of first-line anti-seizure medications as substitution therapy for children with drug-resistant epilepsy: a randomized controlled trial protocol. Front Neurol. 2023 Aug 7;14:1237183. doi: 10.3389/fneur.2023.1237183. eCollection 2023.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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22-09-1097
Identifier Type: -
Identifier Source: org_study_id
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