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Safety/Efficacy Study with CEP-10953 in Treatment of Excessive Sleepiness associated with Chronic SWSD Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Safety/Efficacy Study with CEP-10953 in Treatment of Excessive Sleepiness associated with Chronic SWSD conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Safety/Efficacy Study with CEP-10953 in Treatment of Excessive Sleepiness associated with Chronic SWSD Clinical research trials and Safety/Efficacy Study with CEP-10953 in Treatment of Excessive Sleepiness associated with Chronic SWSD healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Safety/Efficacy Study with CEP-10953 in Treatment of Excessive Sleepiness associated with Chronic SWSD. Safety/Efficacy Study with CEP-10953 in Treatment of Excessive Sleepiness associated with Chronic SWSD Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Safety/Efficacy Study with CEP-10953 in Treatment of Excessive Sleepiness associated with Chronic SWSD clinical trial. Participants typically obtain the most effective healthcare available for their Safety/Efficacy Study with CEP-10953 in Treatment of Excessive Sleepiness associated with Chronic SWSD condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Safety/Efficacy Study with CEP-10953 in Treatment of Excessive Sleepiness associated with Chronic SWSD  Safety/Efficacy Study with CEP-10953 in Treatment of Excessive Sleepiness associated with Chronic SWSD
Safety/Efficacy Study with CEP-10953 in Treatment of Excessive Sleepiness associated with Chronic SWSD
For Condition: Shift Work Sleep Disorder,Excessive Sleepiness
Status: Recruiting
Sponsor(s): Cephalon ,
Synopsis: The primary objective of this study is to determine whether treatment with CEP 10953 is more effective than placebo treatment for patients with excessive sleepiness associated with chronic shift work sleep disorder (SWSD) by measuring mean sleep latency from the Multiple Sleep Latency Test (MSLT) (20 minutes) and by Clinical Global Impression of Change (CGI C) ratings (for sleepiness during night shifts including the commute to and from work) at week 12 (or last postbaseline visit).
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: Patients are included in the study if all of the following criteria are met: - Written informed consent is obtained. - The patient is an outpatient, man or woman of any ethnic origin, 18 to 65 years of age (inclusive). - The patient has a complaint of excessive sleepiness. - The patient has a diagnosis of SWSD according to International Classification of Sleep Disorders (ICSD) criteria, and must have had excessive sleepiness during night shifts for at least 3 months. - The patient must work at least 5 night shifts per month, of which at least 3 nights are consecutive, and plan to maintain this schedule. - The patient must work night shifts that include at least 6 hours between 2200 and 0800 and be no longer than 12 hours in duration. - The patient is in good health as determined by a medical and psychiatric history, physical examination, ECG, and serum chemistry and hematology. - Women must be surgically sterile, 2 years postmenopausal, or, if of child-bearing potential, using a medically accepted method of birth control (ie, barrier method with spermicide, steroidal contraceptive, or intrauterine device [IUD]) and agree to continued use of this method for the duration of the study. Steroidal contraceptives must be used with a barrier method while taking the study drug and for at least a full cycle after discontinuation of the study drug. - The patient has a mean sleep latency of 6 minutes or less as determined by the MSLT - The patient has a CGI-S rating as it pertains to sleepiness during night shifts including the commute to and from work. - The patient does not have any medical or psychiatric disorders that could account for the excessive sleepiness during the night shift. - The patient is able to complete self rating scales and computer-based testing. - The patient is willing and able to comply with study restrictions and to attend regularly scheduled clinic visits as specified in this protocol. Exclusion Criteria: Patients are excluded from participating in this study if 1 or more of the following criteria are met: - has any clinically significant, uncontrolled medical or psychiatric conditions (treated or untreated) - has a probable diagnosis of a current sleep disorder other than SWSD - consumes caffeine including coffee, tea and/or other caffeine containing beverages or food averaging more than 600 mg of caffeine per day - used any prescription drugs disallowed by the protocol or clinically significant use of over the-counter (OTC) drugs within 7 days before the screening/baseline visit - has a history of alcohol, narcotic, or any other drug abuse as defined by the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association, 4th Edition (DSM IV) - has a positive urine drug screen (UDS) at the screening visit - has a clinically significant deviation from normal in the physical examination - is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.) - has used an investigational drug within 1 month before the screening visit - has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery) - has a known clinically significant drug sensitivity to stimulants or modafinil
Total Enrollment: 220
Location and Contact Information:
Brigham & Women's Hospital *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Orfeu Buxton 617-525-7118
Clinilabs, Inc *Recruiting*
New York City, New York, 10025
United States
Recruiting Betsy Ellsworth 212-994-4578
Central Carolina Neurology and Sleep, PA *Recruiting*
Salisbury, North Carolina, 28144
United States
Recruiting Joanne Bollenbecker 704-637-1533
Neurotrials Research Inc *Recruiting*
Atlanta, Georgia, 30342
United States
Recruiting Brenda Richmond 404-851-9934
Henry W. Lahmeyer, MD and Associates *Recruiting*
Northfield, Illinois, 60093
United States
Recruiting Stacy Sloan 847-446-3531
Radiant Research, Salth Lake City, 64th South *Recruiting*
Salt Lake City, Utah, 84107
United States
Recruiting Tiffany Ballingham 801-261-8930
HealthQuest Clinical Trials *Recruiting*
San Diego, California, 92123
United States
Recruiting Lindsay Hampton 858-571-1188
Center for Sleep and Wake Disorders *Recruiting*
Chevy Chase, Maryland, 20815
United States
Recruiting Jaime Stretz 301-654-0209
McLean Hospital Sleep Research Center *Recruiting*
Belmont, Massachusetts, 02478
United States
Recruiting Wendy Tartarini 617-855-2174
Vince and Associates Clinical Research *Recruiting*
Overland Park, Kansas, 66211
United States
Recruiting Angelic McClellan 913-696-1601
VA Medical Center *Recruiting*
Dayton, Ohio, 45428
United States
Recruiting Amanda Dickerson 937-267-3910
Glengrove Clinic Inc. *Recruiting*
Toronto, Ontario, M8X 2W2
Canada
Recruiting Marci Goldstein (416) 236-5650
The Center for Sleep and Wake Disorders/Midwest Neurology *Recruiting*
Danville, Indiana, 46122
United States
Recruiting Carrie Doub 317-718-1403
Ohio Sleep Medicine and Neuroscience Institute, Inc. *Recruiting*
Dublin, Ohio, 43017
United States
Recruiting Jason Davis 614-766-0773
Center for Sleep Disorders, Inc *Recruiting*
Pottstown, Pennsylvania, 19464
United States
Recruiting Karen Hartman-Sloan 610-326-8005
Sleep Disorders Center of SW Florida *Recruiting*
Naples, Florida, 34110
United States
Recruiting Bonnie Adorno-Perez 239-254-1233
ALL-TRIALS Clinical Research, LLC *Recruiting*
Winston Salem, North Carolina, 27103
United States
Recruiting Anissa Carroll 336-659-1500
Saint Vincent Mercy Medical Center - Sleep Disorders Center *Recruiting*
Toledo, Ohio, 43606
United States
Recruiting Michael Neeb 419-251-0591
Pacific Sleep Medicine Services, Inc *Recruiting*
San Diego, California, 92121
United States
Recruiting Maureen Jahraus 858-657-0550
Pacific Sleep Medicine Services, Inc *Recruiting*
Los Angeles, California, 90048
United States
Recruiting Lana Levi 323-653-3434
FutureSearch Trials *Recruiting*
Austin, Texas, 78756
United States
Recruiting Ginger Knight 512-374-0881
Community Resrarch Management Associates, Inc. *Recruiting*
Cincinnati, Ohio, 45219
United States
Recruiting Adam Roth 513-721-3868
Sleep and Neuropsychiatry Centre *Recruiting*
Scarborough, Ontario, M1S 1T7
Canada
Recruiting Lana Romanov (416) 603-5765
SleepMed of South Carolina *Recruiting*
Columbia, South Carolina, 29201
United States
Recruiting Donna James 803-251-3093
Rush University Medical Center *Recruiting*
Chicago, Illinois, 60612-3833
United States
Recruiting Jennifer Kirkby 312-563-4292
Wake Research Associates, LLC *Recruiting*
Raleigh, North Carolina, 27612
United States
Recruiting Amanda Salisbury 919-781-2514
Neurology Associates of Hickory *Recruiting*
Hickory, North Carolina, 28602
United States
Recruiting Teresa Drum 828-345-5060
Toronto West Hospital *Recruiting*
Toronto, Ontario, M5T 2S8
Canada
Recruiting Naheed Hossain (416) 603-5723
Sleep Disorders Center of Alabama *Recruiting*
Birmingham, Alabama, 35213
United States
Recruiting Brett Berry 205-599-1020
Central Arkansas Research *Recruiting*
Hot Springs, Arkansas, 71913
United States
Recruiting Carol Jeffers 501-623-2426
Niagara Clinical Research *Recruiting*
Niagara Falls, Ontario, L2G 1J4
Canada
Recruiting Marion Plumley (905) 374-1405
Sleep Disorders Center of Georgia *Recruiting*
Atlanta, Georgia, 30342
United States
Recruiting Michael Bohannon 404-256-6545
Clinical Research Center of Nevada *Recruiting*
Las Vegas, Nevada, 89104
United States
Recruiting Nina Scharlach 702-893-8968
Additional Information:
Study ID Numbers: C10953/3022/CM/MN;
Study Start Date: December 2003
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00080288
Other Shift Work Sleep Disorder Studies:
1. Safety/Efficacy Study with CEP-10953 in Treatment of Excessive Sleepiness associated with Chronic SWSD
Related Studies:
Other Shift Work Sleep Disorder Clinical Trials
Other Illinois Clinical Trials
Other Northfield Clinical Trials
Safety/Efficacy Study with CEP-10953 in Treatment of Excessive Sleepiness associated with Chronic SWSD
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