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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 Narcolepsy

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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 Narcolepsy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Jun 2024

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At a glance

  • Drugs Solriamfetol (Primary)
  • Indications Narcolepsy
  • Focus Registrational; Therapeutic Use
  • Acronyms TONES-002; TONES-2
  • 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
  • 31 Aug 2021 According to a Jazz pharmaceutical media release, the Health Canada has given approval and availability of Sunosi for the treatment of excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea in adult patients based on data from TONES 2,3 ,4 and 5 trials.Once daily sunosis is approved with doses of 75mg and 150 mg.

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