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NCT00893789 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Efficacy and Safety of Armodafinil as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury
A Phase 3 study, sponsored by Cephalon.
- Terminated
- Registry status
- Phase 3
- Development phase
- 117
- Enrollment target
NCT00893789: Clinical Trial Phase 3 study, sponsored by Cephalon.
NCT00893789 is a Phase 3 study that was terminated before completion, run by Cephalon. The registered enrollment target is 117 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00893789, a Phase 3 study, was terminated before completion, sponsored by Cephalon.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 117 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 mild or moderate closed traumatic brain injury (TBI).
Primary Outcome
The MSLT is an objective assessment of sleepiness that measures the likelihood of falling asleep. Four 20-minute (maximum) MSLT naps were performed at 0900, 1100, 1300, and 1500. The participant, dressed in nonconstricting clothes, was instructed to lie quietly and attempt sleep. Each MSLT nap continued until: (a) 3 consecutive 30-second epochs of stage 1 sleep were reached or (b) any single, 30-second epoch of stage 2, 3, 4, or rapid eye movement (REM) sleep was reached. Sleep latency for each
Interventions
- OTHER Placebo
- DRUG Armodafinil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 117 participants |
| Start Date | 2009-04-30 |
| Est. Completion | 2011-01-31 |
| Phase | Phase 3 |
Why NCT00893789 stopped before completion
NCT00893789 is an interventional study that assigns participants to a tested intervention. The registered 117 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 (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00893789 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00893789 about?
NCT00893789 is a clinical study titled "Study to Evaluate the Efficacy and Safety of Armodafinil as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury". 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 mild or moderate closed traumatic brain injury (TBI).
What is the current status of trial NCT00893789?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 117 participants. The study started on 2009-04-30. Estimated completion is 2011-01-31.
What interventions are being tested in trial NCT00893789?
The interventions under investigation include: Placebo (OTHER), Armodafinil (DRUG).
Who is sponsoring clinical trial NCT00893789?
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 NCT00893789's enrollment target sits among peer trials
117 1642nd of 2000 higher than 358 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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