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NCT00983437 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Safety, Tolerability, and Efficacy of Armodafinil as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury
A Phase 3 study, sponsored by Cephalon.
- Terminated
- Registry status
- Phase 3
- Development phase
- 49
- Enrollment target
NCT00983437: Clinical Trial Phase 3 study, sponsored by Cephalon.
NCT00983437 is a Phase 3 study that was terminated before completion, run by Cephalon. The registered enrollment target is 49 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00983437, a Phase 3 study, was terminated before completion, sponsored by Cephalon.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 49 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the safety and tolerability of long-term (12 months) armodafinil treatment in patients with excessive sleepiness associated with mild or moderate closed traumatic brain injury (TBI).
Primary Outcome
AE=any untoward medical occurrence that develops or worsens in severity during the conduct of the clinical study of a pharmaceutical product and does not necessarily have a causal relationship to the study drug. SAE=any AE that resulted in any of the following: death; a life-threatening adverse event; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; a congenital anomaly or birth defect; an important medical event that require
Interventions
- DRUG Armodafinil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2009-08-31 |
| Est. Completion | 2011-01-31 |
| Phase | Phase 3 |
Why NCT00983437 stopped before completion
NCT00983437 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Armodafinil is the first listed.
NCT00983437 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00983437 about?
NCT00983437 is a clinical study titled "Study to Evaluate the Safety, Tolerability, and Efficacy of Armodafinil as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury". The primary objective of this study is to evaluate the safety and tolerability of long-term (12 months) armodafinil treatment in patients with excessive sleepiness associated with mild or moderate closed traumatic brain injury (TBI).
What is the current status of trial NCT00983437?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 49 participants. The study started on 2009-08-31. Estimated completion is 2011-01-31.
What interventions are being tested in trial NCT00983437?
The interventions under investigation include: Armodafinil (DRUG).
Who is sponsoring clinical trial NCT00983437?
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 NCT00983437's enrollment target sits among peer trials
49 1860th of 2000 higher than 139 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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