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NCT00758498 · ClinicalTrials.gov registry record · Phase 3
Study of the Effect of Armodafinil Treatment in Healthy Subjects With Excessive Sleepiness Associated With Jet Lag Disorder
A Phase 3 study of Excessive Sleepiness, sponsored by Cephalon.
- Completed
- Registry status
- Phase 3
- Development phase
- 427
- Enrollment target
- 4
- Study locations
NCT00758498: Completed Phase 3 study of Excessive Sleepiness, sponsored by Cephalon.
NCT00758498 is a Phase 3 study of Excessive Sleepiness that has completed, run by Cephalon. The registered enrollment target is 427 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00758498, a Phase 3 study of Excessive Sleepiness, has completed, sponsored by Cephalon.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 427 participants
- Enrollment target
- 4
- Study locations
Study 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.
Primary Outcome
MSLT is an assessment that measures likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep. On Treatment Days 1 and 2 the subject was instructed on 4 occasions to attempt to fall asleep. Each MSLT nap continued until 3 consecutive 30-second epochs of stage 1 sleep were reached, or any 30 second epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 minutes if no sleep occured. Average sleep latency for the 4 naps was tabulated
Conditions Studied
Interventions
- DRUG placebo
- DRUG armodafinil
Study Locations (4)
Georgia
- Neurotrials Research, Inc. - Atlanta
Kentucky
- Community Research - Crestview
New York
- Clinilabs, Inc. - New York
South Carolina
- SleepMed of South Carolina - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 427 participants |
| Start Date | 2008-09 |
| Est. Completion | 2009-02 |
| Phase | Phase 3 |
What the finished NCT00758498 record still lists
NCT00758498 is an interventional study that assigns participants to a tested intervention. The registered 427 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 (45% lower).
The record links to 1 condition, with Excessive Sleepiness appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT00758498 reports a single indexed study location in Georgia, Kentucky, New York.
Frequently Asked Questions
What is clinical trial NCT00758498 about?
NCT00758498 is a clinical study titled "Study of the Effect of Armodafinil Treatment in Healthy Subjects With Excessive Sleepiness Associated With Jet Lag Disorder". 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.
What is the current status of trial NCT00758498?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 427 participants. The study started on 2008-09. Estimated completion is 2009-02.
What conditions does trial NCT00758498 study?
This clinical trial studies the following conditions: Excessive Sleepiness.
What interventions are being tested in trial NCT00758498?
The interventions under investigation include: placebo (DRUG), armodafinil (DRUG).
Who is sponsoring clinical trial NCT00758498?
This trial is sponsored by Cephalon, which has 64 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00758498 being conducted?
This trial has 4 study locations across Georgia, Kentucky, New York, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Excessive Sleepiness
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00758498's enrollment target sits among peer trials
427 880th of 2000 higher than 1,119 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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