NCT00893789

Study to Evaluate the Efficacy and Safety of Armodafinil as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury

A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil (50, 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: 117 (actual)
• Sponsor: Cephalon, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to determine whether armodafinil treatment is more effective than placebo treatment in patients with excessive sleepiness associated with mild or moderate closed traumatic brain injury (TBI).

Conditions

• Traumatic Brain Injury

Interventions

Type	Name	Description
DRUG	Armodafinil	Armodafinil 50 mg/day
DRUG	Armodafinil	Armodafinil 150 mg/day
DRUG	Armodafinil	Armodafinil 250 mg/day
OTHER	Placebo	Placebo

Timeline

• Start date: 2009-04-30
• Primary completion: 2011-01-31
• Completion: 2011-01-31
• First posted: 2009-05-06
• Last updated: 2021-12-17
• Results posted: 2013-10-18

Locations

73 sites across 4 countries: United States, Germany, Italy, Spain