Abstracts

Rationale: To evaluate the efficacy, safety, and tolerability of add-on lacosamide therapy against focal seizures in young children aged ≥ 1 month to ≤ 4 years.

Methods: This non-randomized, open-label, and self-controlled real-world study included 105 children aged ≥ 1 month to ≤ 4 years with focal seizures treated with add-on lacosamide therapy at Children's Hospital of Chongqing Medical University.

Results: (1) The 50% response rates at 3, 6, 9, and 12 months of follow-up were 58.1%, 61.0%, 57.1%, and 56.2%, while the seizure-free rates at the same time points were 27.6%, 34.3%, 32.4%, and 37.1%, respectively. The 50% response rate of using LCM as the first add-on treatment for focal seizures was much higher than as the second and later added treatment at 3 month (p = 0.038). After one year of follow-up, the pediatric patients showed a significant improvement in neurodevelopmental levels (p < 0.05). (2) The retention rate of add-on lacosamide therapy was 72.7% (64/88) after 1 year of follow-up. The efficacy of lacosamide and the occurrence of serious adverse events were independent risk factors for the retention rate of lacosamide. (3) During add-on lacosamide therapy, 13 (12.4%) patients reported adverse events, and five (4.7%) patients withdrew due to adverse events, including vomiting drowsiness, ataxia (0.94%), neck itching with eczema (0.94%), irritability (1.88%) and gastrointestinal discomfort (0.94%). No drug-related skin adverse events were observed.