Conditions: Chronic Shift Work Sleep Disorder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 136
Healthy volunteers: no

Brief 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

Arms:
arm 1: PROVIGIL 200 mg/day arm 2: Armodafinil 250 mg/day arm 3: Armodafinil 200 mg/day arm 4: Armodafinil 150 mg/day arm 5: Placebo

Interventions: intervention 1: PROVIGIL 200 mg intervention 2: Armodafinil 250 mg intervention 3: Armodafinil 200 mg intervention 4: Armodafinil 150 mg intervention 5: Placebo
Intervention descriptions: intervention 1: PROVIGIL 200 mg/day intervention 2: Armodafinil 250 mg/day intervention 3: Armodafinil 200 mg/day intervention 4: Armodafinil 150 mg/day intervention 5: Matching placebo tablets

Protocol document: