Epilepsia Open (Mar 2023)

Safety and tolerability of short‐term infusions of intravenous lacosamide in pediatric patients with epilepsy: An open‐label, phase 2/3 trial

  • Mark Kristof Farkas,
  • Cynthia Beller,
  • Ali Bozorg,
  • Carrie McClung,
  • Robert Roebling,
  • Tanisia Yates,
  • Nancy Yuen,
  • Iryna Makedonska

DOI
https://doi.org/10.1002/epi4.12682
Journal volume & issue
Vol. 8, no. 1
pp. 146 – 153

Abstract

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Abstract Objective The objective of this study is to evaluate the safety and tolerability of intravenous (IV) lacosamide infusion in patients aged ≥1 month to <17 years with epilepsy. Methods This Phase 2/3 open‐label trial (EP0060; NCT02710890) enrolled patients in two age cohorts (cohort 1: ≥8 to <17 years; cohort 2: ≥1 month to <8 years). Eligible patients were receiving oral lacosamide as adjunctive treatment or monotherapy (in an open‐label long‐term trial or by prescription) or were not receiving lacosamide before enrolment. Patients initiated IV lacosamide (2‐12 mg/kg/day or 100‐600 mg/day; 15‐60 minutes infusion) as a replacement for oral lacosamide or as adjunctive treatment. The primary outcomes were treatment‐emergent adverse events (TEAEs) and discontinuations due to TEAEs. Results In total, 103 patients were enrolled and completed the trial; 55 patients were included in cohort 1 (≥8 to <17 years), 48 in cohort 2 (≥1 month to <8 years). During the 4 weeks before screening, 74 (71.8%) patients had focal seizures, 12 (11.7%) had generalized seizures, and two (1.9%) had unclassified seizures. Most patients (74 [71.8%]) initiated lacosamide as adjunctive IV treatment. The mean overall duration of exposure to IV lacosamide was 1.18 days. Seventy‐nine (76.7%) patients had one IV lacosamide infusion, 20 (19.4%) had two, one (1.0%) had three, and three (2.9%) had 10 infusions. Overall, five (4.9%) patients had a total of seven TEAEs. The only TEAEs reported in two or more patients were increased blood triglycerides (two [1.9%]). No serious or severe TEAEs were reported, and no patients discontinued due to TEAEs. No TEAEs were considered drug‐related by the investigator. No consistent or clinically relevant treatment‐related changes from baseline were observed for hematology, clinical chemistry parameters, vital signs, or 12‐lead electrocardiograms. Significance IV lacosamide was generally well tolerated in pediatric patients (≥1 month to <17 years) with epilepsy, and no new safety concerns were identified.

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