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A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Obstructive Sleep Apnea (OSA)

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Trial Profile

A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Obstructive Sleep Apnea (OSA)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Jun 2024

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At a glance

  • Drugs Solriamfetol (Primary)
  • Indications Sleep apnoea syndrome
  • Focus Registrational; Therapeutic Use
  • Acronyms TONES 3
  • Sponsors Jazz Pharmaceuticals Inc

Most Recent Events

  • 18 Apr 2024 Results assessing effect size (ES), number-needed-to-treat (NNT), and number-needed-to-harm (NNH), statistical representations of efficacy and tolerability in excessive daytime sleepiness presented at the 76th Annual Meeting of the American Academy of Neurology 2024
  • 01 Nov 2022 Results of secondary analysis from two trials (TONES 2, TONES 3) assessing Efficacy and safety of Solriamfetol treatment of excessive daytime sleepiness in participants with narcolepsy or obstructive sleep apnea with a history of depressionpublished in the Journal of Psychiatric Research
  • 07 Sep 2022 According to an Axsome Therapeutics media release, post-hoc analysis results from NCT02348606 and NCT02348619 were published in the Journal of Psychiatric Research.

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