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

Completed
Phase of Trial: Phase III

Latest Information Update: 20 Dec 2017

At a glance

  • Drugs Solriamfetol (Primary)
  • Indications Narcolepsy
  • Focus Registrational; Therapeutic Use
  • Acronyms TONES-002
  • Sponsors Jazz Pharmaceuticals Inc
  • Most Recent Events

    • 20 Dec 2017 According to a Jazz Pharmaceuticals media release, based on the results of this trial, comapny has submitted an New Drug Application (NDA) to the U.S. Food and Drug Administration, seeking for the marketing approval of solriamfetol (JZP-110) for the treatment of excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea (OSA).
    • 19 Oct 2017 Status changed from active, no longer recruiting to completed.
    • 07 Jun 2017 According to a Jazz Pharmaceuticals media release, data from this trial were presented at the 31st Associated Professional Sleep Societies (APSS) Annual SLEEP Meeting.
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