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NCT00078312 · ClinicalTrials.gov registry record · Phase 3
Armodafinil (CEP-10953) for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder
A Phase 3 study, sponsored by Cephalon.
- Completed
- Registry status
- Phase 3
- Development phase
- 328
- Enrollment target
NCT00078312: Completed Phase 3 study, sponsored by Cephalon.
NCT00078312 is a Phase 3 study that has completed, run by Cephalon. The registered enrollment target is 328 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00078312, a Phase 3 study, has completed, sponsored by Cephalon.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 328 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the safety and tolerability of Armodafinil (CEP-10953) administered on a flexible-dosage regimen of 100 to 250 mg/day for up to 12 months to patients with excessive sleepiness associated with a current diagnosis of narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS)(regular users of nasal continuous positive airway pressure \[nCPAP\] therapy), or chronic shift work sleep disorder (SWSD).
Primary Outcome
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 for seriousness listed previously will be regarded as a nonserious adverse event.
Interventions
- DRUG CEP-10953 (Armodafinil)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 328 participants |
| Start Date | 2004-01 |
| Est. Completion | 2006-07 |
| Phase | Phase 3 |
What the finished NCT00078312 record still lists
NCT00078312 is an interventional study that assigns participants to a tested intervention. The registered 328 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 (58% lower).
The record links to 0 conditions, and to 1 intervention - of which CEP-10953 (Armodafinil) is the first listed.
NCT00078312 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00078312 about?
NCT00078312 is a clinical study titled "Armodafinil (CEP-10953) for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder". The primary objective of this study is to evaluate the safety and tolerability of Armodafinil (CEP-10953) administered on a flexible-dosage regimen of 100 to 250 mg/day for up to 12 months to patients with excessive sleepiness associated with a current diagnosis of narcolepsy, obstructive sleep apne...
What is the current status of trial NCT00078312?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 328 participants. The study started on 2004-01. Estimated completion is 2006-07.
What interventions are being tested in trial NCT00078312?
The interventions under investigation include: CEP-10953 (Armodafinil) (DRUG).
Who is sponsoring clinical trial NCT00078312?
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 NCT00078312's enrollment target sits among peer trials
328 1074th of 2000 higher than 926 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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