Trials / Completed
CompletedNCT00228553
Extension Study of the Safety and Efficacy of Armodafinil in the Treatment of Patients With Excessive Sleepiness
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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 743 (actual)
- Sponsor
- Cephalon · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
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
Conditions
- Excessive Daytime Sleepiness
- Narcolepsy
- Obstructive Sleep Apnea/Hypopnea Syndrome
- Chronic Shift Work Sleep Disorder
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Armodafinil 100 to 250 mg/day | Armodafinil 100-250 mg: once daily in the morning for patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) or narcolepsy, once daily only on nights worked for patients with shift worker sleep disorder (SWSD). |
Timeline
- Start date
- 2004-05-01
- Completion
- 2006-07-01
- First posted
- 2005-09-29
- Last updated
- 2013-07-19
- Results posted
- 2010-03-31
Locations
100 sites across 7 countries: United States, Australia, Canada, France, Germany, Puerto Rico, Russia
Source: ClinicalTrials.gov record NCT00228553. Inclusion in this directory is not an endorsement.