drugset / Trial / NCT00078312

Armodafinil (CEP-10953) for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder

NCT00078312

Phase 3 Completed 328 enrolled Cephalon
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The primary objective of this study is to evaluate the safety and tolerability of Armodafinil (CEP-10953) administered on a flexible-dosage regimen of 100 to 250 mg/day for up to 12 months to patients with excessive sleepiness associated with a current diagnosis of narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS)(regular users of nasal continuous positive airway pressure \[nCPAP\] therapy), or chronic shift work sleep disorder (SWSD).

Timeline

Start
2004-01
Primary completion
2006-07
Completion
2006-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Armodafinil Small molecule 100 mg Oral
Subject Armodafinil Small molecule 250 mg Oral