Trials / Terminated
TerminatedNCT00983437
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 12-Month, Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of Armodafinil (150 and 250 mg/Day) as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 49 (actual)
- Sponsor
- Cephalon, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Armodafinil |
Timeline
- Start date
- 2009-08-31
- Primary completion
- 2011-01-31
- Completion
- 2011-01-31
- First posted
- 2009-09-24
- Last updated
- 2021-12-17
- Results posted
- 2013-10-18
Locations
61 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00983437. Inclusion in this directory is not an endorsement.