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NCT00518986 · ClinicalTrials.gov registry record · Phase 4
Efficacy and Safety of Armodafinil for Adults With Excessive Sleepiness Obstructive Sleep Apnea/Hypopnea and Depression
A Phase 4 study, sponsored by Cephalon.
- Completed
- Registry status
- Phase 4
- Development phase
- 249
- Enrollment target
NCT00518986: Completed Phase 4 study, sponsored by Cephalon.
NCT00518986 is a Phase 4 study that has completed, run by Cephalon. The registered enrollment target is 249 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00518986, a Phase 4 study, has completed, sponsored by Cephalon.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 249 participants
- Enrollment target
Study Summary
The primary objective of the study is to evaluate whether armodafinil at a target dosage of 200 mg/day is more effective than placebo treatment in improving excessive sleepiness in patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) who have comorbid major depressive disorder or dysthymic disorder.
Primary Outcome
MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of 4 30-minute periods (0900, 1100, 1300, and 1500) reclining in dark room. Each period was terminated immediately after sleep onset or at end of 30 minutes if no sleep occurred. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to Endpoint (12 weeks or last observation after baseline) in mean sleep latency avera
Interventions
- DRUG placebo
- DRUG armodafinil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 249 participants |
| Start Date | 2007-10 |
| Est. Completion | 2009-03 |
| Phase | Phase 4 |
What the finished NCT00518986 record still lists
NCT00518986 is an interventional study that assigns participants to a tested intervention. The registered 249 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00518986 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00518986 about?
NCT00518986 is a clinical study titled "Efficacy and Safety of Armodafinil for Adults With Excessive Sleepiness Obstructive Sleep Apnea/Hypopnea and Depression". The primary objective of the study is to evaluate whether armodafinil at a target dosage of 200 mg/day is more effective than placebo treatment in improving excessive sleepiness in patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) who have comorbid major depressive disorder or dysthymi...
What is the current status of trial NCT00518986?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 249 participants. The study started on 2007-10. Estimated completion is 2009-03.
What interventions are being tested in trial NCT00518986?
The interventions under investigation include: placebo (DRUG), armodafinil (DRUG).
Who is sponsoring clinical trial NCT00518986?
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 NCT00518986's enrollment target sits among peer trials
249 353rd of 2000 higher than 1,648 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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