People Suffering Excessive Sleepiness During the Day Resulting From a Concussion Sought by Medical Centers for Research Study

King of Prussia, PA–June 1, 2010 –June is Great Outdoors Month and, across the nation, people are being encouraged to get out and about. For many, sports activities are a great way to get outdoors. But for tens of thousands of people every year, sports such as cycling, baseball, basketball and skateboarding can result in head injuries such as concussions.1 The impact of a concussion can be felt even years after the injury and may include long-term excessive sleepiness during the day.2,3,4 A new clinical study is underway to evaluate an investigational treatment option for this under-recognized symptom of head injury for which currently no medications have been approved by the US Food and Drug Administration.

Clinical research sites across the world are working with biopharmaceutical company Cephalon, Inc., as part of the study to test the effectiveness and safety of an investigational treatment for people with excessive sleepiness caused by a concussion or head injury. For this study, they are seeking adults (18 to 65 years old) who continue to have excessive sleepiness due to a concussion or head injury that happened at least 1 year ago and within the past 10 years.5 People who think they may qualify for this study are encouraged to call 1-877-674-6317 or visit www.HeadInjuryResearchStudy.com. Those eligible to take part in the study will receive study-related medical care by medical professionals at no cost.

“It is common for people who have a concussion or head injury to go on to suffer from sleep-wake disturbances, such as excessive sleepiness,”3 explained Gregory Rippon, MD, board-certified neurologist and Senior Director of Clinical Research at Cephalon. “Feeling excessively sleepy during the day can seriously affect your quality of life.”3

The effects of a concussion or head injury can range from feeling dizzy for a short while to being knocked out.6 Many who have a concussion can also experience excessive sleepiness during the day – a condition where people can feel tired or low on energy even after a good night’s sleep.4 Most people will fully recover in a matter of days or weeks; but, for some, the effects can last for several years after the original injury.2

# # #

About the Study Sponsor
Cephalon is a global biopharmaceutical company dedicated to discovering, developing and bringing to market medications to improve the quality of life of individuals around the world. Since its inception in 1987, Cephalon has brought first-in-class and best-in-class medicines to patients in several therapeutic areas. Cephalon has the distinction of being one of the world’s fastest-growing biopharmaceutical companies, now among the Fortune 1000 and a member of the S&P 500 Index, employing approximately 4,000 people worldwide. The company sells numerous branded and generic products around the world. In total, Cephalon sells more than 150 products in nearly 100 countries. More information on Cephalon and its products is available at http://www.cephalon.com.

Sources

1. Centers for Disease Control and Prevention. Nonfatal traumatic brain injuries from sports and recreation activities – United States, 2001–2005. Morbidity and Mortality Weekly Report 2007; 56: 733–7. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5629a2.htm (accessed 4/27/10)
2. A Sterr, KA Herron, C Hayward, Daniela Montaldi. Are mild head injuries as mild as we think? Neurobehavioral concomitants of chronic post-concussion syndrome. BMC Neurology 2006, 6:7. Available from: http://www.biomedcentral.com/1471-2377/6/7.
3. Baumann CR, Werth E, Stocker R, Ludwig S, Bassetti CL. Sleep–wake disturbances 6 months after traumatic brain injury: a prospective study. Brain 2007; 130: 1973–83.
4. National Institute of Neurological Diseases and Stroke (NINDS), National Institutes of Health (NIH). Hypersomnia. http://www.ninds.nih.gov/disorders/hypersomnia/hypersomnia.htm (accessed 5/10/10)
5. www.headinjuryresearchstudy.com/participate (accessed 4/27/10).
6. Centers for Disease Control and Prevention. Injury prevention & control: traumatic brain injury. Concussions in sport. http://www.cdc.gov/concussion/sports/recognize.html (accessed 5/10/10)

Information for editors:

• For further information on concussions, visit: http://www.cdc.gov/concussion/index.html.
• Estimated annual number of emergency department visits for all nonfatal traumatic brain injuries related to sports and recreation activities, by activity – National Electronic Injury Surveillance System – All Injury Program, US, 2001–2005.1

• Bicycle: 40,424
• Football: 22,689
• Playground: 16,130
• Basketball: 14,680
• All terrain vehicle: 11,199
• Baseball: 10,103
• Soccer: 9,371
• Horseback riding: 8,650
• Swimming/diving: 5,878
• Skateboard: 5,292
• Hockey (ice/field/roller/street): 5,194
• Moped/mini-bike/dirt bike: 4,736
• Softball: 4,277
• Exercise: 4,163
• Miscellaneous ball games (incl. lacrosse, rugby, handball, tetherball): 3,814
• Combative (incl. boxing, wrestling, martial arts, fencing): 3,682
• Scooter: 3,534
• Gymnastics (incl. cheerleading, dancing): 2,951
• Toboggan/sled: 2,687
• Golf: 2,687
• Ice skating: 2,411
• Trampoline: 2,131
• In-line skating: 1,610
• Skating (other): 1,457
• Amusement attractions: 1,391
• Go-cart: 1,243
• Volleyball: 1,170
• Racquet sports (incl. tennis, badminton, squash): 723
• Bowling: 394
• Track and field: 305
• Other specified (incl. water skiing, surfing, personal watercraft, snow skiing, snowmobile, snowboarding): 12,852

Contact information
Ann Armellei, Healthcare Communications Coordinator
MediciGlobal, 1014 West 9th Avenue, King of Prussia, PA 19406
(P) 484-674-6835
(F) 484-674-6356
aarmellei@mediciglobal.com
www.mediciglobal.com

No Medicines Currently Approved to Treat Sleepiness During the Day for People Suffering from Head Injuries

King of Prussia, PA– January 12, 2010 – Local patients are being sought for a national clinical research study currently investigating a study medication for people who have had a head injury, concussion or bump on the head and feel sleepy or tired during the day.  According to the Centers for Disease Control and Prevention, head injury is one of the most common neurologic disorders, affecting around 1.5 million Americans every year. Many people with a past head injury feel sleepy during the day, yet few people know that their sleepiness might be connected to this injury.  People experiencing daytime sleepiness who have had one head injury within the last 10 years are encouraged to contact the clinical research screening center at 1-877-674-6317 or go to www.HeadInjuryResearchStudy.com  for more information and where they can take the pre-screening questionnaire to see if they are eligible for the study.

“Currently, there are no treatments for patients who suffer from sleepiness during the day as a result of head injury,” according to study investigator Dr. Milton Erman, MD at Avastra Clinical Trials. “Consequently, there is a great need for new medicines to treat this life-changing problem.”

The clinical study is specifically designed for adults aged 18 to 65 who have had a head injury, concussion, or bump on the head within the last 10 years and feel sleepy or tired during the day. It will examine different dosage strengths of the study medicine and how patients respond to them. Eligible participants may receive medical care related to the study at no cost and be reimbursed for time and travel as a result of taking part in the trial.

A recent online survey of more than 100 people who have had a previous head injury found that feeling sleepy during the day negatively affects their work and family life. The survey was conducted by MediciGlobal, a patient communications firm working with Cephalon, Inc., the biopharmaceutical company sponsoring the study.

“Seventy percent of head injury sufferers surveyed said that their daytime sleepiness affects their ability to effectively interact with their family and co-workers, and seriously impacts long-term relationships,” said Dr. Erman.  “This study is important because daytime sleepiness can negatively impact the daily lives of so many patients suffering from head injuries.”

# # #

About the Study Sponsor
Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and commercialization of many unique products in four core therapeutic areas: central nervous system, inflammatory diseases, pain and oncology.