KING OF PRUSSIA, Pa., June 1 /PRNewswire/ -- 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.
- 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).
- 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.
- 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.
- 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).
- http://www.headinjuryresearchstudy.com/participate.php (accessed 4/27/10).
- 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).