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

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.

Timeline

Start

2023-03-01

Primary completion

2023-05-30

Completion

2023-06-30

Publications

• 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.

Drugs

Indications