NCT00236080

Study of the Efficacy and Multiple-Dose Plasma Concentration-Time Profiles of Armodafinil and PROVIGIL

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Multiple-Dose Plasma Concentration-Time Profiles of Armodafinil (150, 200, and 250 mg) and PROVIGIL® (200 mg) in Patients With Chronic Shift Work Sleep Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Cephalon · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to compare the overnight efficacy and plasma concentration-time profiles of armodafinil and PROVIGIL, after multiple doses, in patients with excessive sleepiness associated with chronic Shift Work Sleep Disorder (SWSD).

Detailed description

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Multiple-Dose Plasma Concentration-Time Profiles of Armodafinil and PROVIGIL in Patients with Chronic Shift Work Sleep Disorder

Conditions

• Chronic Shift Work Sleep Disorder

Interventions

Type	Name	Description
DRUG	PROVIGIL 200 mg	PROVIGIL 200 mg/day
DRUG	Armodafinil 250 mg	Armodafinil 250 mg/day
DRUG	Armodafinil 200 mg	Armodafinil 200 mg/day
DRUG	Armodafinil 150 mg	Armodafinil 150 mg/day
DRUG	Placebo	Matching placebo tablets

Timeline

• Start date: 2005-08-01
• Completion: 2005-12-01
• First posted: 2005-10-12
• Last updated: 2013-07-19
• Results posted: 2010-02-03

Locations

20 sites across 1 country: United States