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NCT00236080 · ClinicalTrials.gov registry record · Phase 3
Study of the Efficacy and Multiple-Dose Plasma Concentration-Time Profiles of Armodafinil and PROVIGIL
A Phase 3 study, sponsored by Cephalon.
- Completed
- Registry status
- Phase 3
- Development phase
- 136
- Enrollment target
NCT00236080: Completed Phase 3 study, sponsored by Cephalon.
NCT00236080 is a Phase 3 study that has completed, run by Cephalon. The registered enrollment target is 136 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00236080, a Phase 3 study, has completed, sponsored by Cephalon.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 136 participants
- Enrollment target
Study 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).
Primary Outcome
The Multiple Sleep Latency Test (MSLT) is an objective assessment of sleepiness that measures the likelihood of falling asleep. Five 20-minute (maximum) MSLT naps were performed (at 2300, 0100, 0300, 0500, and 0700) at both the screening/baseline assessment visit (Visit 2) and at endpoint (Visit 4). Each nap was terminated after 20 minutes if no sleep occurred. Sleep latency was measured as the elapsed time from lights out to the first epoch scored as sleep.
Interventions
- DRUG Placebo
- DRUG PROVIGIL 200 mg
- DRUG Armodafinil 250 mg
- DRUG Armodafinil 200 mg
- DRUG Armodafinil 150 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2005-08 |
| Est. Completion | 2005-12 |
| Phase | Phase 3 |
What the finished NCT00236080 record still lists
NCT00236080 is an interventional study that assigns participants to a tested intervention. The registered 136 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT00236080 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00236080 about?
NCT00236080 is a clinical study titled "Study of the Efficacy and Multiple-Dose Plasma Concentration-Time Profiles of Armodafinil and PROVIGIL". 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).
What is the current status of trial NCT00236080?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 136 participants. The study started on 2005-08. Estimated completion is 2005-12.
What interventions are being tested in trial NCT00236080?
The interventions under investigation include: Placebo (DRUG), PROVIGIL 200 mg (DRUG), Armodafinil 250 mg (DRUG), Armodafinil 200 mg (DRUG), Armodafinil 150 mg (DRUG).
Who is sponsoring clinical trial NCT00236080?
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 NCT00236080's enrollment target sits among peer trials
136 1580th of 2000 higher than 419 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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