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Safety and Efficacy Study of CEP-10953 in the Treatment of Excessive Sleepiness Associated with Narcolepsy Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Safety and Efficacy Study of CEP-10953 in the Treatment of Excessive Sleepiness Associated with Narcolepsy conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Safety and Efficacy Study of CEP-10953 in the Treatment of Excessive Sleepiness Associated with Narcolepsy Clinical research trials and Safety and Efficacy Study of CEP-10953 in the Treatment of Excessive Sleepiness Associated with Narcolepsy health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Safety and Efficacy Study of CEP-10953 in the Treatment of Excessive Sleepiness Associated with Narcolepsy. Safety and Efficacy Study of CEP-10953 in the Treatment of Excessive Sleepiness Associated with Narcolepsy Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Safety and Efficacy Study of CEP-10953 in the Treatment of Excessive Sleepiness Associated with Narcolepsy clinical trial. Test subjects typically receive the most expert healthcare available for their Safety and Efficacy Study of CEP-10953 in the Treatment of Excessive Sleepiness Associated with Narcolepsy condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Safety and Efficacy Study of CEP-10953 in the Treatment of Excessive Sleepiness Associated with Narcolepsy  Safety and Efficacy Study of CEP-10953 in the Treatment of Excessive Sleepiness Associated with Narcolepsy
Safety and Efficacy Study of CEP-10953 in the Treatment of Excessive Sleepiness Associated with Narcolepsy
For Condition: Narcolepsy
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 narcolepsy by measuring mean sleep latency from the Maintenance of Wakefulness (MWT) (20-minute version)(average of 4 naps at 0900, 1100, 1300, and 1500) and by the Clinical Global Impressions of Change (CGI-C) ratings (as related to general condition) at week 12 (or last postbasline 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: Diagnosis and Criteria for Inclusion: 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 current diagnosis of narcolepsy according to ICSD criteria. - The patient is in good health as determined by a medical and psychiatric history, physical examination, electrocardiogram (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 [oral, implanted, and Depo-Provera contraceptives must be used in conjunction with a barrier method], or intrauterine device [IUD]) and agree to continued use of this method for the duration of the study. - The patient has a mean sleep latency of 6 minutes or less as determined by the Multiple Sleep Latency Test (MSLT) (performed at 0900, 1100, 1300, and 1500). - The patient has a CGI-S (Clinical Global Impression of Severity of Illness) rating of 4 or more. - The patient does not have any medical or psychiatric disorders that could account for the excessive daytime sleepiness. - 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. Criteria for Exclusion: 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 narcolepsy - consume 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 second screening 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 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: 300
Location and Contact Information:
Center for Sleep and Wake Disorders *Recruiting*
Chevy Chase, Maryland, 20815
United States
Recruiting Jaime Stretz 301-654-0209
Depression & Anxiety Institute *Recruiting*
Mount Kisco, New York, 10549
United States
Recruiting Simon Rego 914-241-2735
HealthSouth Clinical Research *Recruiting*
Conroe, Texas, 77384
United States
Recruiting Nichelle Nixon 281-364-3380
Sleep-Wake Disorder Center of Winter Park *Recruiting*
Winter Park, Florida, 32789
United States
Recruiting Maria Lopez 407-740-5447
Sleep Disorder Centre *Recruiting*
Winnipeg, Manitoba, R2H 2A6
Canada
Recruiting Zoe Pouliot (204) 253-3678
Advanced Clinical Research Institute *Recruiting*
Anaheim, California, 92801
United States
Recruiting Linda Gozar 714-778-1300
Clinical Research Group of St. Petersburg *Recruiting*
St. Petersburg, Florida, 33707
United States
Recruiting Mary O'Brien 727-360-0853
Sleep Disorders Center of Sourtwest Florida *Recruiting*
Naples, Florida, 34110
United States
Recruiting Bonnie Adorno-Perez 239-254-1233
Center for Sleep & Wake Disorders *Recruiting*
Chevy Chase, Maryland, 20815
United States
Recruiting Jaime Stretz 301-654-0209
Washington University Multidisciplinary Sleep Medicine Center *Recruiting*
St. Louis, Missouri, 63108
United States
Recruiting Christine Doerr 314-747-0643
Swedish Sleep Medicine Institute *Recruiting*
Seattle, Washington, 98122
United States
Recruiting Dallas Parman 206-386-3714
The Center for Sleep & Wake Disorders/Midwest Neurology *Recruiting*
Danville, Indiana, 46122
United States
Recruiting Carrie Doub 317-718-1403
Hôpital Antoine Béclère *Recruiting*
Clamart Cedex, , 92141
France
Recruiting Pierre Escourrou +33(0)1 45 37 48 19
Sleepmed, Inc. *Recruiting*
Macon, Georgia, 31201
United States
Recruiting Hope Kilgore 478-745-9050
Tri-State Sleep Disorders Center *Recruiting*
Cincinnati, Ohio, 45246
United States
Recruiting Kathy Smith 513-671-3101
University of Regensburg *Recruiting*
Regensburg, , 93042
Germany
Recruiting Peter Geisler +49-941-941 80 12
Clinical Pharmaceutical Trials, Inc. *Recruiting*
Tulsa, Oklahoma, 74104
United States
Recruiting Julianne Mayo 918-743-4374
Radiant Research *Recruiting*
Salt Lake City, Utah, 84107
United States
Recruiting Amy Holman 801-261-8930
Toronto West Hospital *Recruiting*
Toronto, Ontario, M5T 2S8
Canada
Recruiting Naheed Hossain 416-603-5723
Hephata Klinik *Recruiting*
Schwalmstadt, , 34613
Germany
Recruiting Geert Mayer +49-6691-18 20 02
Pacific Sleep Medicine Services, Inc. *Recruiting*
San Diege, California, 92121
United States
Recruiting Minnie Kuo 858-657-0550
Community Research & Sleep Management Institute *Recruiting*
Crestview, Kentucky, 41017
United States
Recruiting Adam Roth 513-721-3868
Ohio Sleep Medicine and Neuroscience Institute, Inc. *Recruiting*
Dublin, Ohio, 43017
United States
Recruiting Jason Davis 614-766-0773
SleepMed of South Carolina *Recruiting*
Columbia, South Carolina, 29201
United States
Recruiting Donna James 803-251-3093
University of Freiburg *Recruiting*
Freiburg, , 79104
Germany
Recruiting Dieter Riemann +49-761-270 66 03
HĂ´pitaux Universitaires de Strasbourg - HĂ´pital Civil *Recruiting*
Strasbourg Cedex, , 67091
France
Recruiting Jean Kreiger +33(0)3 88 11 64 30
Sleep Disorders Centers of Alabama *Recruiting*
Birmingham, Alabama, 35213
United States
Recruiting Sheila Pegram 205-599-1020
Neurotrials Research Inc. *Recruiting*
Atlanta, Georgia, 30342
United States
Recruiting Brenda Richmond 404-851-9934
Thomas Jefferson University Sleep Disorders Center at Methodist Hospital *Recruiting*
Philadelphia, Pennsylvania, 19148
United States
Recruiting Diana Chism 215-955-2795
CHU - HĂ´pital de Rangueil *Recruiting*
Toulouse Cedex 9, , 31059
France
Recruiting Michel Tiberge +33(0)5 61 32 26 96
Forrest General Hospital Sleep Disorders Center *Recruiting*
Hattiesburg, Mississippi, 39401
United States
Recruiting Carolyn McLarnan 601-288-1998
Additional Information:
Study ID Numbers: C10953/3020/NA/MN;
Study Start Date: December 2003
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00078377
Other Narcolepsy Studies:
1. Safety and efficacy of Xyrem oral solution (sodium oxybate) compared with placebo in narcoleptic patients
2. Trial Comparing Effects of Xyrem taken Orally and Modafinil with Placebo in Treating Daytime Sleepiness in Narcolepsy
3. Safety and Efficacy Study of CEP-10953 in the Treatment of Excessive Sleepiness Associated with Narcolepsy
4. CEP-10953 for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder
5. Sleep Disorders of Patients with Diseases of the Nervous System
Related Studies:
Other Narcolepsy Clinical Trials
Other Ohio Clinical Trials
Other Cincinnati Clinical Trials
Safety and Efficacy Study of CEP-10953 in the Treatment of Excessive Sleepiness Associated with Narcolepsy
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