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.

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.

Completed
Phase of Trial: Phase III

Latest Information Update: 18 Jul 2013

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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top