A 12-Month, Open-Label, Flexible-Dosage (100 to 250 mg/Day) Extension Study of the Safety and Efficacy of Armodafinil (CEP-10953) in the Treatment of Patients With Excessive Sleepiness Associated With Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder (With an Open-Ended Extension Period).

Trial Profile

A 12-Month, Open-Label, Flexible-Dosage (100 to 250 mg/Day) Extension Study of the Safety and Efficacy of Armodafinil (CEP-10953) in the Treatment of Patients With Excessive Sleepiness Associated With Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder (With an Open-Ended Extension Period).

Completed
Phase of Trial: Phase III

Latest Information Update: 23 Dec 2010

At a glance

  • Drugs Armodafinil (Primary)
  • Indications Somnolence
  • Focus Adverse reactions; Registrational
  • Sponsors Cephalon
  • Most Recent Events

    • 06 Apr 2010 Offcial title, primary outcomes amended and actual number of patients (743) added as reported by ClinicalTrials.gov record.
    • 13 Nov 2007 Status changed from in progress to completed.
    • 26 Jul 2007 The expected completion date for this trial is now 1 Jan 2005.
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