CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 136 enrolled
Drug / intervention
PROVIGIL 200 mg +4 moredrug
Likely dose
Armodafinil 150, 200, or 250 mg once daily, or modafinil (PROVIGIL) 200 mg once dailyAI-extracted
Key inclusion· 6
  • ✓Diagnosis of shift work sleep disorder (SWSD) per ICSD criteria with excessive sleepiness during night shifts for ≥3 months
  • ✓Planning to work 3–5 nights per week with ≥3 consecutive nights
  • ✓Night shifts between 6 and 12 hours duration, including time between 22:00 and 08:00
  • ✓Mean sleep latency ≤6 minutes on Multiple Sleep Latency Test (MSLT)
Key exclusion· 7
  • ✕Current sleep disorder other than SWSD
  • ✕Caffeine intake >600 mg/day within 2 weeks of study drug start
  • ✕Positive urine drug screen without medical explanation
  • ✕Known or suspected hypersensitivity to stimulants and/or modafinil or any ingredient in study drug

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00236080
NCT00236080Phase 3Completed
CompareCT.gov

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

Cephalon·interventional·Posted Oct 12, 2005·Updated Jul 19, 2013

In Brief

A Phase 3 clinical trial evaluating PROVIGIL 200 mg, Armodafinil 250 mg, and 3 other interventions for Chronic Shift Work Sleep Disorder. Completed, enrolled 136 participants across 20 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Shift Work Sleep Disorder
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 12, 2005
Enrollment StartAug 1, 2005
Study CompletionDec 1, 2005
TodayJul 2, 2026
Posted 20.7 years ago

Interventions

PROVIGIL 200 mgdrug

PROVIGIL 200 mg/day

Armodafinil 250 mgdrug

Armodafinil 250 mg/day

Armodafinil 200 mgdrug

Armodafinil 200 mg/day

Armodafinil 150 mgdrug

Armodafinil 150 mg/day

Placebodrug

Matching placebo tablets