NCT00228566

Study to Assess Patient Reported Outcomes With Armodafinil Treatment for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome

A Short-term (8 Week) Open-Label Study, Followed by a Long Term Evaluation, to Assess Patient-Reported Outcomes With Armodafinil Treatment (150 to 250 mg/Day) for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 247 (actual)
• Sponsor: Cephalon · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess patient reported outcomes with armodafinil treatment in terms of improvement in sleepiness, satisfaction with treatment, impact on ability to engage in life activities (ie, daily or work and family and/or social activities), and effects on fatigue. Clinician ratings on patient response to armodafinil treatment will also be assessed.

Conditions

• Excessive Daytime Sleepiness
• Narcolepsy
• Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS)

Interventions

Type	Name	Description
DRUG	Armodafinil

Timeline

• Start date: 2005-10-01
• Completion: 2006-07-01
• First posted: 2005-09-29
• Last updated: 2013-07-19
• Results posted: 2010-06-25

Locations

43 sites across 1 country: United States