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NCT00228553 · ClinicalTrials.gov registry record · Phase 3
Extension Study of the Safety and Efficacy of Armodafinil in the Treatment of Patients With Excessive Sleepiness
A Phase 3 study, sponsored by Cephalon.
- Completed
- Registry status
- Phase 3
- Development phase
- 743
- Enrollment target
NCT00228553: Completed Phase 3 study, sponsored by Cephalon.
NCT00228553 is a Phase 3 study that has completed, run by Cephalon. The registered enrollment target is 743 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00228553, a Phase 3 study, has completed, sponsored by Cephalon.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 743 participants
- Enrollment target
Study Summary
A 12 Month, Open-Label, Flexible Dosage Extension Study of the Safety and Efficacy of Armodafinil (CEP-10953) in the Treatment of Patients with Excessive Sleepiness Associated with Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder
Primary Outcome
An adverse event is any untoward medical occurrence in a patient that develops or worsens in severity during the conduct of a clinical study. Serious and Non-serious Adverse Events (SAEs). Serious adverse event is any adverse event occurring at any dose that results in any of the following outcomes: death, life-threatening, inpatient hospitalization, persistent or significant disability, congenital anomaly, or an important medical event. An adverse event that does not meet any of the criteria fo
Interventions
- DRUG Armodafinil 100 to 250 mg/day
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 743 participants |
| Start Date | 2004-05 |
| Est. Completion | 2006-07 |
| Phase | Phase 3 |
What the finished NCT00228553 record still lists
NCT00228553 is an interventional study that assigns participants to a tested intervention. The registered 743 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Armodafinil 100 to 250 mg/day is the first listed.
NCT00228553 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00228553 about?
NCT00228553 is a clinical study titled "Extension Study of the Safety and Efficacy of Armodafinil in the Treatment of Patients With Excessive Sleepiness". A 12 Month, Open-Label, Flexible Dosage Extension Study of the Safety and Efficacy of Armodafinil (CEP-10953) in the Treatment of Patients with Excessive Sleepiness Associated with Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder
What is the current status of trial NCT00228553?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 743 participants. The study started on 2004-05. Estimated completion is 2006-07.
What interventions are being tested in trial NCT00228553?
The interventions under investigation include: Armodafinil 100 to 250 mg/day (DRUG).
Who is sponsoring clinical trial NCT00228553?
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 NCT00228553's enrollment target sits among peer trials
743 476th of 2000 higher than 1,525 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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