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Safety, tolerability, and efficacy of adjunctive lacosamide in pediatric patients with epilepsy syndromes associated with generalized seizures: Phase 2, open-label exploratory trial.

Stėphane AuvinAlexis A ArzimanoglouCynthia BellerFlorin FloricelTony DanielsAli Bozorg
Published in: Epilepsia (2023)
Safety findings were consistent with the known safety profile of lacosamide and were as expected for the pediatric population. There was no worsening of generalized seizures with lacosamide. Limitations include the inability to correlate spike and wave data with clinical outcomes, and lack of similar studies against which the results can be compared.
Keyphrases
  • open label
  • phase iii
  • phase ii
  • clinical trial
  • study protocol
  • randomized controlled trial
  • phase ii study
  • electronic health record
  • machine learning
  • double blind
  • case control
  • placebo controlled