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

NCT05697614 | Unknown Phase 4

• 1 other identifier: 22-09-1097
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Drug Resistant Epilepsy

Keywords

anti-epilepsy drug; children; epilepsy; resistant

Outcome Measures

Primary Outcomes (1)

• the different proportion of responders between groups who get first-line anti-epileptic drugs (intervention) and second-line anti-epileptic drugs (control)

  responders are children who get the reduction of seizure frequency by 50%

  trough the study completion, about 14 weeks

Secondary Outcomes (22)

• time to achieve the reduction of seizure frequency by 50% or more among responders

  during intervention, about 12 weeks

• the difference of quality of life between groups who get first-line anti-epileptic drugs (intervention) and second-line anti-epileptic drugs (control)

  at baseline phase in the 1st week (before intervention) and after intervention in the 14th week

• the difference of the electroencephalography (EEG) changing between groups who get first-line anti-epileptic drugs (intervention) and second-line anti-epileptic drugs (control)

  at baseline phase in the 1st week (before intervention) and after intervention in the 14th week

• the description of age in percentage

  at baseline phase in the 1st week (before intervention)

• the description of seizure onset in percentage

  at baseline phase in the 1st week (before intervention)

Study Arms (2)

intervention

EXPERIMENTAL

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

Drug: Valproic acid; Drug: Carbamazepin; Drug: Phenytoin

control

ACTIVE COMPARATOR

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

Drug: Lamotrigine; Drug: Clobazam; Drug: Oxcarbazepine

Interventions

Valproic acid DRUG

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

Also known as: sodium divalproex, depaken

intervention

Carbamazepin DRUG

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

Also known as: tegretol, bamgetol

intervention

Phenytoin DRUG

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

Also known as: kutoine

intervention

Lamotrigine DRUG

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

Also known as: lamictal

control

Clobazam DRUG

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

Also known as: frisium

control

Oxcarbazepine DRUG

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

Also known as: trileptal

control

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children age at 1 - 18 years old
• Children diagnosed as drug-resistant epilepsy by pediatric neurologists, diagnosis was based on the ILAE 2017 criteria
• 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

You may not qualify if:

• Non-convulsive epilepsy
• 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
• substitution therapy that will be given

Sponsors & Collaborators

• Dr Cipto Mangunkusumo General Hospital: lead

Study Sites (3)

Cipto Mangunkusumo Hospital

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

RECRUITING

Harapan Kita Hospital

Jakarta, 11420, Indonesia

RECRUITING

Fatmawati Hospital

Jakarta, 12430, Indonesia

RECRUITING

Related Publications (1)

• 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.

  PMID: 37609651 DERIVED

MeSH Terms

Conditions

Drug Resistant Epilepsy; Epilepsy

Interventions

Valproic Acid; Carbamazepine; Phenytoin; Lamotrigine; Clobazam; Oxcarbazepine

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hydantoins; Imidazolidines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Triazines; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring

Study Officials

• Roro Rukmi Windi Perdani Pediatrician

  Cipto Mangunkusumo Hopsital - Medical Faculty of Indonesia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roro Rukmi Windi Perdani Pediatrician

CONTACT

+6281373679940; rororwp@gmail.com

Wawaimuli Arozal Ph.D

CONTACT

+6281808408680; wawaimuli@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: The subjects will be randomized into 2 groups : intervention and control. The subjects will be recruited by consecutive sampling technique

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: January 26, 2023
• Study Start: March 1, 2023
• Primary Completion: May 30, 2023
• Study Completion: June 30, 2023
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

ID (3)