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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

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: 30 Jan 2023

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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

    • 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.
    • 25 Jun 2020 Results (n=231) assessing sub-group analysis of efficacy and safety in cataplexy status, published in the CNS Drugs.
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