Lacosamide's Promise in Neonatal Seizure Management: A Phase 2 Trial's Insights
A groundbreaking phase 2 clinical trial has shed light on lacosamide's potential in managing neonatal seizures, showcasing its efficacy and safety in reducing seizure activity and ensuring patient tolerability. The study, led by Dr. Wendy Waldman Zadeh, a neurologist at Broadlawns Medical Center, Des Moines, Iowa, involved 26 patients with repeated electroencephalographic neonatal seizures (ENS).
The trial, named SP0968 (NCT04519645), was a multicenter, randomized, open-label, active comparator (AC) study. It revealed that lacosamide significantly reduced seizure burden while being well-tolerated by neonates. Interestingly, despite higher exposure to lacosamide in neonates, serum concentrations remained consistent with adult levels at a 400 mg/day dose, without the presence of inducers.
The study's primary focus was on the change in seizure burden, measured as minutes of electrographic neonatal seizures per hour, from baseline to the evaluation period. It also assessed treatment-emergent adverse events (TEAEs) and mean serum concentrations of lacosamide. Rescue medication was allowed when needed, but patients who received it within 3 hours after the initial dose were excluded from primary efficacy analysis.
Among the 26 patients, 14 were assigned to the lacosamide group and 12 to the AC group. The median reduction in seizure burden was notably higher in the lacosamide group (4.74 min/h) compared to the AC group (2.51 min/h). Impressively, 60% of patients in both groups responded to the treatment, with 80% response rates in 60% of lacosamide recipients and 44% of AC recipients. Moreover, 64.3% of lacosamide patients and 75% of AC patients were seizure-free at 24 hours.
Adverse events were generally mild, with 64.3% of lacosamide patients experiencing 21 TEAEs, and 7.1% of patients in both groups reporting drug-related TEAEs. The geometric mean serum concentration of lacosamide was consistently maintained at 7.003 μg/mL and 5.949 μg/mL at 30-90 minutes and 6-8 hours post-infusion, respectively.
This study builds upon previous research, including a retrospective cohort trial demonstrating lacosamide's effectiveness in treating refractory trigeminal neuralgia. The findings suggest that lacosamide could be a valuable alternative for patients with trigeminal neuralgia who have not responded to first-line treatments, further expanding its therapeutic potential.
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