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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 is a Phase 3 study that has completed, run by Cephalon. The registered enrollment target is 328 participants.
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).
Interventions
- DRUG CEP-10953 (Armodafinil)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 328 participants |
| Start Date | 2004-01 |
| Est. Completion | 2006-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00078312
The ClinicalTrials.gov registry entry for NCT00078312 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 328 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cephalon, which has 64 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CEP-10953 (Armodafinil) is the first listed.
NCT00078312 reports 0 study locations.
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.
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