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A 3-Day, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Armodafinil Treatment (50 and 150 mg/Day) in Healthy Subjects With Excessive Sleepiness Associated With Jet Lag Disorder.

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Trial Profile

A 3-Day, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Armodafinil Treatment (50 and 150 mg/Day) in Healthy Subjects With Excessive Sleepiness Associated With Jet Lag Disorder.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 Jul 2013

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At a glance

  • Drugs Armodafinil (Primary)
  • Indications Jet lag
  • Focus Therapeutic Use
  • Sponsors Cephalon

    • Most Recent Events

    • 27 Dec 2010 According to a Cephalon media release, a second Complete Response Letter from the US FDA has been received for the sNDA based on this trial. Cephalon believes that this application will not be approved, and is no longer pursuing this indication.
    • 01 Jul 2010 Results have been published in the Mayo Clinic Proceedings.
    • 24 Sep 2009 Armodafinil has been granted priority review. The decision on approval is expected by 29 Dec, 2009, according to a Cephalon media release.

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