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Levetiracetam Versus Phenobarbital for Neonatal Seizures: A Randomized Controlled Trial

Cynthia Sharpe1,2, Gail E Reiner2, Suzanne L Davis1

  • 1Department of Paediatric Neurology, Starship Children's Health, Auckland, New Zealand.

Pediatrics
|May 10, 2020
PubMed

Insights

Phenobarbital was more effective than levetiracetam for treating neonatal seizures in a phase IIb trial. Phenobarbital showed higher seizure control, but levetiracetam had fewer adverse effects, warranting further study.

Area of Science:

  • Neonatal neurology
  • Pediatric epilepsy
  • Clinical pharmacology

Background:

  • No US Food and Drug Administration-approved therapies exist for neonatal seizures.
  • Phenobarbital and phenytoin are common treatments but often fail and raise safety concerns for the developing brain.
  • Levetiracetam shows promise due to its efficacy and safety profile in older patients.

Purpose of the Study:

  • To compare the efficacy and safety of levetiracetam versus phenobarbital as a first-line treatment for neonatal seizures.
  • To evaluate levetiracetam's potential as an alternative first-line therapy for neonatal seizures.

Main Methods:

  • A multicenter, randomized, blinded, controlled, phase IIb trial.
  • Investigated levetiracetam compared with phenobarbital for neonatal seizures of any cause.
  • Primary outcome: complete seizure freedom for 24 hours, assessed by independent EEG review.

Main Results:

  • Phenobarbital achieved 24-hour seizure freedom in 80% of patients, versus 28% for levetiracetam (P < .001).
  • A levetiracetam dose escalation from 40 to 60 mg/kg improved efficacy by 7.5%.
  • More adverse effects were observed in the phenobarbital group, though not statistically significant.

Conclusions:

  • Phenobarbital demonstrated superior efficacy compared to levetiracetam in this phase IIb study for neonatal seizures.
  • Phenobarbital treatment was associated with higher rates of adverse effects.
  • Further research with higher doses of levetiracetam and long-term outcome measures is needed.
Abstract

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