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  Excessive Sleepiness associated with Mild to Moderate Closed Traumatic Brain Injury  
 
 
  Title: 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.  
 
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  Summary  
 
 
  The primary objective to this study is to determine whether Armodafinil is more effective than placebo in patients with excessive sleepiness associated with a head injury through measurements using overnight sleep studies and measuring day time naps.  
   
  How Can You Qualify?  
 
 
  Participants may be eligible to participate in this clinical research study for excessive sleepiness associated with head injury if the following criteria are met: • Between 18 and 65 years old • Received a concussion or similar head injury 1-10yrs ago (without loss of consciousness greater than 30 minutes) • Made a very good recovery after head injury • Now experiencing excessive daytime sleepiness • Are willing to participate in a 15 week study • Are willing to attend 7 office visits (5 overnight stays and 4 daytime stays) All study related visits, laboratory work, study medication, meals on assessment days, and all study related procedures are provided at no cost. Qualified participants will receive at no cost; study related physical exams, study medication, study-related laboratory tests and compensation for time and travel.  
   
  Principal Investigator  
 
 
  Ashokkumar C. Patel, M.D.    
   
  Contact  
 
 
  Katie Yarosh, Lisa Bess  -  (570) 585-6228   or   yyarosh@gminstitutes.com  
   
  Location  
 
 
  Sleep Lab of Northeastern Pennsylvania - Clarks Summit, Pennsylvania  
   
   
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