At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 427 enrolled
Drug / intervention
armodafinil +2 moredrug
Likely dose
armodafinil 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 3-Day, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Armodafinil Treatment (50 and 150 mg/Day) in Healthy Subjects With Excessive Sleepiness Associated With Jet Lag Disorder
In Brief
A Phase 3 clinical trial evaluating armodafinil and placebo for Excessive Sleepiness. Completed, enrolled 427 participants across 4 sites.
Detailed Summary
This is a randomized, double-blind, placebo-controlled, parallel-group study of armodafinil and placebo treatment in healthy subjects with excessive sleepiness associated with jet lag disorder.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsExcessive Sleepiness
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2008
First PostedSep 2008
Primary CompletionFeb 2009
TodayJul 2026
First PostedSep 25, 2008
Enrollment StartSep 1, 2008
Primary CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 17.8 years ago
Interventions
armodafinildrug
50 mg/day orally, once daily in the morning for 3 days
armodafinildrug
150 mg/day orally, once daily in the morning for 3 days
placebodrug
placebo tablets, once daily in the morning for 3 days