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NCT01096680 · ClinicalTrials.gov registry record · Phase 2
Pharmacodynamic Profile of SPD489 in Healthy Adult Males Undergoing a Nocturnal Period of Acute Sleep Loss
A Phase 2 study, sponsored by Shire.
- Completed
- Registry status
- Phase 2
- Development phase
- 135
- Enrollment target
NCT01096680: Completed Phase 2 study, sponsored by Shire.
NCT01096680 is a Phase 2 study that has completed, run by Shire. The registered enrollment target is 135 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01096680, a Phase 2 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 135 participants
- Enrollment target
Study Summary
This is a double-blind, single center, parallel group, placebo and active comparator, controlled study to characterize the wake promoting effects of single doses of SPD489 in healthy adult male undergoing acute sleep deprivation.
Primary Outcome
The MWT was conducted to determine the subjects' ability to stay awake. Subjects sat in a darkened room and were told to "stay awake as long as possible" during the 30 minute session. This is an indicator of how well you are able to function and remain alert in quiet times of inactivity. Higher times are better.
Interventions
- DRUG Placebo
- DRUG Armodafinil
- DRUG SPD489 20 mg
- DRUG SPD489 50 mg
- DRUG SPD489 70 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2010-04-05 |
| Est. Completion | 2010-07-18 |
| Phase | Phase 2 |
What the finished NCT01096680 record still lists
NCT01096680 is an interventional study that assigns participants to a tested intervention. The registered 135 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT01096680 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01096680 about?
NCT01096680 is a clinical study titled "Pharmacodynamic Profile of SPD489 in Healthy Adult Males Undergoing a Nocturnal Period of Acute Sleep Loss". This is a double-blind, single center, parallel group, placebo and active comparator, controlled study to characterize the wake promoting effects of single doses of SPD489 in healthy adult male undergoing acute sleep deprivation.
What is the current status of trial NCT01096680?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 135 participants. The study started on 2010-04-05. Estimated completion is 2010-07-18.
What interventions are being tested in trial NCT01096680?
The interventions under investigation include: Placebo (DRUG), Armodafinil (DRUG), SPD489 20 mg (DRUG), SPD489 50 mg (DRUG), SPD489 70 mg (DRUG).
Who is sponsoring clinical trial NCT01096680?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01096680's enrollment target sits among peer trials
135 532nd of 2000 higher than 1,464 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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