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NCT01080807 · ClinicalTrials.gov registry record · Phase 4
Efficacy and Tolerability of Armodafinil in Adults With Excessive Sleepiness Associated With Shift Work Disorder
A Phase 4 study, sponsored by Cephalon.
- Completed
- Registry status
- Phase 4
- Development phase
- 385
- Enrollment target
NCT01080807: Completed Phase 4 study, sponsored by Cephalon.
NCT01080807 is a Phase 4 study that has completed, run by Cephalon. The registered enrollment target is 385 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01080807, a Phase 4 study, has completed, sponsored by Cephalon.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 385 participants
- Enrollment target
Study Summary
The primary objective of the study is to determine whether armodafinil treatment is more effective than placebo treatment in patients with excessive sleepiness associated with shift work disorder (SWD) by measuring improved clinical condition late in the shift, including the commute home.
Primary Outcome
The Clinical Global Impression of Change (CGI-C) is an assessment performed by the clinician, evaluating the change in the patient's symptoms over time. The clinician categorizes the change as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. The data presented here represents the percentage of patients whose condition showed at least minimal improvement in the CGI-C rating as related to late shift sleepiness (defined as the perio
Interventions
- DRUG Matching Placebo
- DRUG Armodafinil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 385 participants |
| Start Date | 2010-03 |
| Est. Completion | 2010-10 |
| Phase | Phase 4 |
What the finished NCT01080807 record still lists
NCT01080807 is an interventional study that assigns participants to a tested intervention. The registered 385 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (26% lower).
The record links to 0 conditions, and to 2 interventions - of which Matching Placebo is the first listed.
NCT01080807 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01080807 about?
NCT01080807 is a clinical study titled "Efficacy and Tolerability of Armodafinil in Adults With Excessive Sleepiness Associated With Shift Work Disorder". The primary objective of the study is to determine whether armodafinil treatment is more effective than placebo treatment in patients with excessive sleepiness associated with shift work disorder (SWD) by measuring improved clinical condition late in the shift, including the commute home.
What is the current status of trial NCT01080807?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 385 participants. The study started on 2010-03. Estimated completion is 2010-10.
What interventions are being tested in trial NCT01080807?
The interventions under investigation include: Matching Placebo (DRUG), Armodafinil (DRUG).
Who is sponsoring clinical trial NCT01080807?
This trial is sponsored by Cephalon, which has 64 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01080807's enrollment target sits among peer trials
385 222nd of 2000 higher than 1,779 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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