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)

NCT00228553 Phase 3 COMPLETED Results posted

A 12 Month, Open-Label, Flexible Dosage 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

Details

Lead sponsor	Cephalon
Phase	Phase 3
Status	COMPLETED
Enrolment	743
Start date	2004-05
Completion	2006-07

Conditions

• Excessive Daytime Sleepiness
• Narcolepsy
• Obstructive Sleep Apnea/Hypopnea Syndrome
• Chronic Shift Work Sleep Disorder

Interventions

• Armodafinil 100 to 250 mg/day

Primary outcomes

• Safety and Tolerability in This Patient Population (Narcolepsy, OSAHS, SWSD) Over Time (up to 2 Years) — End of months 1, 3, 6, 9, and 12 and every 3 months for up to an additional year
  An adverse event is any untoward medical occurrence in a patient that develops or worsens in severity during the conduct of a clinical study. Serious and Non-serious Adverse Events (SAEs). Serious adverse event is any adverse event occurring at any dose that results in any of the following outcomes: death, life-threatening, inpatient hospitalization, persistent or significant disability, congenital anomaly, or an important medical event. An adverse event that does not meet any of the criteria for seriousness listed previously will be regarded as a nonserious adverse event.

Countries

United States, Australia, Canada, France, Germany, Puerto Rico, Russia