Protocol for a prospective cohort study in Southwest China assessing the effectiveness and safety of lacosamide monotherapy in paediatric epilepsy patients aged ≤16 years.

Abstract

Epilepsy ranks as one of the most prevalent neurological disorders, with poorly controlled seizures imposing a significant disease burden. Subclinical epileptiform discharges (SEDs) have been linked to cognitive and behavioural impairments in children. There is a growing trend in clinical practices towards increased use of antiseizure medications (ASMs), as they have the potential to alleviate the impact of SEDs in children. Nonetheless, 25-30% of epilepsy patients do not respond to current antiepileptic treatments. Lacosamide (LCM), a third-generation ASM, has demonstrated established efficacy and tolerability in both adults and children with epilepsy. However, there is a scarcity of studies on LCM as a monotherapy for paediatric patients with epilepsy and SEDs. This study aims to assess the efficacy and safety of LCM monotherapy in epilepsy patients, as well as to examine the impact of LCM on patients with SED. This prospective cohort study, conducted at a single centre and employing an open-label approach, aims to administer LCM antiepileptic treatment to children while taking into account their seizure profiles, electroencephalogram results, cognitive development and other relevant factors. The index date, marking the administration of the first LCM dose, defines the beginning of the study. The baseline period encompasses the 3 months leading up to the index date, and each child will be monitored until the addition, switch or discontinuation of study drugs, death, completion of a full 1-year follow-up or the conclusion of the study period. Assessments will be conducted every 3 months throughout the follow-up period. This study received approval from the Ethics Committee of the Children's Hospital Affiliated with Chongqing Medical University (file number: 2024-210), and all participating sites have obtained the necessary approvals. This study has been registered with the Chinese Clinical Trial Registry. Written informed consent will be sought from the parents or guardians of potential participants under 16 years of age at the outpatient clinic. Additionally, older children with normal cognitive function will be asked to provide their own version of written informed consent. Participation in the study is voluntary, and individuals or their parents/guardians who choose not to provide consent will not be included in the study. ChiCTR2400092710.