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NCT00711516 · ClinicalTrials.gov registry record · Phase 4
Study to Evaluate Armodafinil Treatment in Improving Prefrontal Cortical Activation and Working Memory Performance
A Phase 4 study, sponsored by Cephalon.
- Completed
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
NCT00711516: Completed Phase 4 study, sponsored by Cephalon.
NCT00711516 is a Phase 4 study that has completed, run by Cephalon. The registered enrollment target is 40 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00711516, a Phase 4 study, has completed, sponsored by Cephalon.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
Study Summary
The primary objective of this study is to determine whether treatment with armodafinil will provide improvements in prefrontal cortical activation in patients with OSAHS (Obstructive Sleep Apnea/Hypopnea Syndrome) who have residual sleepiness despite receiving nCPAP therapy.
Primary Outcome
The primary outcome was the change from baseline in number of contiguous activated voxels in the dorsolateral prefrontal cortex (DLPFC) on functional magnetic resonance imaging (fMRI) at Week 2(or last observation after baseline). Each voxel is compared to the reference wave form. If it differs from that value p\<0.05, the voxel is considered active. fMRI is a brain imaging technique that identifies neuronal activation related to specific tasks or sensory stimulation. Increased neuronal activity
Interventions
- DRUG Placebo
- DRUG Armodafinil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2008-09 |
| Est. Completion | 2009-10 |
| Phase | Phase 4 |
What the finished NCT00711516 record still lists
NCT00711516 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00711516 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00711516 about?
NCT00711516 is a clinical study titled "Study to Evaluate Armodafinil Treatment in Improving Prefrontal Cortical Activation and Working Memory Performance". The primary objective of this study is to determine whether treatment with armodafinil will provide improvements in prefrontal cortical activation in patients with OSAHS (Obstructive Sleep Apnea/Hypopnea Syndrome) who have residual sleepiness despite receiving nCPAP therapy.
What is the current status of trial NCT00711516?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2008-09. Estimated completion is 2009-10.
What interventions are being tested in trial NCT00711516?
The interventions under investigation include: Placebo (DRUG), Armodafinil (DRUG).
Who is sponsoring clinical trial NCT00711516?
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 NCT00711516's enrollment target sits among peer trials
40 1397th of 2000 higher than 533 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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