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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 is a Phase 3 study that was terminated before completion, run by Cephalon. The registered enrollment target is 49 participants.
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).
Interventions
- DRUG Armodafinil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2009-08-31 |
| Est. Completion | 2011-01-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00983437
The ClinicalTrials.gov registry entry for NCT00983437 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 49 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 Armodafinil is the first listed.
NCT00983437 reports 0 study locations.
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.
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