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Efficacy and Safety of Lower-Sodium Oxybate in an Open-Label Titration Period of a Phase 3 Clinical Study in Adults with Idiopathic Hypersomnia.

Michael J ThorpyIsabelle ArnulfNancy Foldvary-SchaeferAnne Marie MorseKarel SonkaPatricia ChandlerLuke HickeyAbby ChenJed BlackAmanda SterkelDan ChenRichard K BoganYves Dauvilliers
Published in: Nature and science of sleep (2022)
During open-label treatment with LXB, participants showed clinically meaningful improvements in idiopathic hypersomnia symptoms and in quality of life and functional measures. TEAE incidence declined over LXB titration and optimization.
Keyphrases
  • open label
  • clinical trial
  • risk factors
  • phase ii
  • combination therapy
  • phase iii
  • double blind
  • physical activity
  • sleep quality
  • replacement therapy