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CEP-10953 in Treatment of Excessive Sleepiness Associated with Obstructive Sleep Apnea/Hypopnea (OSA/H) Syndrome Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about CEP-10953 in Treatment of Excessive Sleepiness Associated with Obstructive Sleep Apnea/Hypopnea (OSA/H) Syndrome conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. CEP-10953 in Treatment of Excessive Sleepiness Associated with Obstructive Sleep Apnea/Hypopnea (OSA/H) Syndrome Clinical research trials and CEP-10953 in Treatment of Excessive Sleepiness Associated with Obstructive Sleep Apnea/Hypopnea (OSA/H) Syndrome health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as CEP-10953 in Treatment of Excessive Sleepiness Associated with Obstructive Sleep Apnea/Hypopnea (OSA/H) Syndrome. CEP-10953 in Treatment of Excessive Sleepiness Associated with Obstructive Sleep Apnea/Hypopnea (OSA/H) Syndrome Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a CEP-10953 in Treatment of Excessive Sleepiness Associated with Obstructive Sleep Apnea/Hypopnea (OSA/H) Syndrome clinical trial. Human subjects frequently get the finest healthcare available for their CEP-10953 in Treatment of Excessive Sleepiness Associated with Obstructive Sleep Apnea/Hypopnea (OSA/H) Syndrome condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > CEP-10953 in Treatment of Excessive Sleepiness Associated with Obstructive Sleep Apnea/Hypopnea (OSA/H) Syndrome  CEP-10953 in Treatment of Excessive Sleepiness Associated with Obstructive Sleep Apnea/Hypopnea (OSA/H) Syndrome
CEP-10953 in Treatment of Excessive Sleepiness Associated with Obstructive Sleep Apnea/Hypopnea (OSA/H) Syndrome
For Condition: Sleep Apnea, Obstructive,Sleep Apnea Syndromes
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 obstructive sleep apnea/hypopnea syndrome (OSAHS) by measuring mean sleep latency from the Maintenance of Wakefulness Test (MWT) (30-minute version) (average of 4 naps at 0900, 1100, 1300, and 1500) and by Clinical Global Impression of Change (CGI-C) ratings (as related to general condition) 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: (a) Written informed consent is obtained. (b) The patient is an outpatient, man or woman of any ethnic origin, 18 to 65 years of age (inclusive). (c) The patient has a complaint of excessive sleepiness despite nCPAP therapy being effective and being a regular user of nCPAP therapy. (d) The patient has a current diagnosis of OSAHS according to International Classification of Sleep Disorders (ICSD) criteria. (e) The patient meets the following nCPAP therapy requirements: - Adequate education and intervention efforts to encourage nCPAP therapy use must be documented. - A patient’s nCPAP therapy regimen must be stable for at least 4 weeks. - nCPAP therapy is shown to be effective, with effectiveness defined as having an apnea-hypopnea index (AHI) of 10 or less during nocturnal PSG, and, in the opinion of the investigator, nCPAP is effective therapy. - Following demonstration of effectiveness, evidence of regular nCPAP usage must be shown during a 2-week evaluation period (ie, nCPAP usage for at least 4 hours/night on at least 70% of the nights). (f) The patient is in good health as determined by a medical and psychiatric history, physical examination, ECG, and serum chemistry and hematology. (g) 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. (h) The patient has a Clinical Global Impression of Severity of Illness (CGI-S) rating of 4 or more. (i) The patient has an ESS score of 10 or more. (j) The patient does not have any medical or psychiatric disorders that could account for the excessive sleepiness. (k) The patient is able to complete self rating scales and computer-based testing. (l) 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: (a) has any clinically significant, uncontrolled medical or psychiatric conditions (treated or untreated) (b) has a probable diagnosis of a current sleep disorder other than OSAHS (c) consumes caffeine including coffee, tea and/or other caffeine containing beverages or food averaging more than 600 mg of caffeine per day (d) 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 (e) 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) (f) has a positive urine drug screen (UDS) (g) has a clinically significant deviation from normal in the physical examination (h) is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.) (i) has used an investigational drug within 1 month before the initial screening visit (j) has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery) (k) has a known clinically significant drug sensitivity to stimulants or modafinil
Total Enrollment: 324
Location and Contact Information:
PsyPharma Clinical Research, Inc. *Recruiting*
Phoenix, Arizona, 85050
United States
Recruiting Ann Jacobs 602-992-3115
Clinilabs, Inc. *Recruiting*
New York City, New York, 10025
United States
Recruiting Betsy Ellsworth 212-994-4578
Sleep Medicine Associates of Texas, PA *Recruiting*
Plano, Texas, 75093
United States
Recruiting Jan Dodd 972-312-0204
ALL-TRIALS Clinical Research, LLC *Recruiting*
Winston Salem, North Carolina, 27103
United States
Recruiting Anissa Carroll 336-659-1500
Duke University Medical Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Linda Ollis 919-681-8789
Baylor College of Medicine, VAMC Sleep Research Program *Recruiting*
Houston, Texas, 77030
United States
Recruiting Charmaine Brown 713-794-7896
Glengrove Clinic Inc. *Recruiting*
Toronto, Ontario, M8X 2W2
Canada
Recruiting Marci Goldstein (416) 450-5851
Clinical Research Group of St. Petersburg *Recruiting*
St. Petersburg, Florida, 33707
United States
Recruiting Mary O'Brien 727-360-0853
Vince and Associates Clinical Research *Recruiting*
Overland Park, Kansas, 66211
United States
Recruiting Angelic McClellan 913-696-1601
Clinical Research Center of Nevada *Recruiting*
Las Vegas, Nevada, 89104
United States
Recruiting Darlene Steljes 702-893-8968
SleepMed of South Carolina *Recruiting*
Columbia, South Carolina, 29201
United States
Recruiting Donna James 803-251-3093
Sleep Disorders Center of Sourtwest Florida *Recruiting*
Naples, Florida, 34110
United States
Recruiting Bonnie Adorno-Perez 239-254-1233
VA Medical Center *Recruiting*
Dayton, Ohio, 45428
United States
Recruiting Michael Bonnet 937-267-3910
Canadian Sleep Institute-CSI Research *Recruiting*
Calgary, Alberta, T2X 2A8
Canada
Recruiting Laree Fordyce (403) 254-6400
St. John's Medical Plaza, Sleep Disorders Center *Recruiting*
Santa Monica, California, 90404
United States
Recruiting Alex Harris 310-586-0843
Sleep Disorders Center of Georgia *Recruiting*
Atlanta, Georgia, 30342
United States
Recruiting Michael Bohannon 404-256-6545
Advanced Clinical Research Institute *Recruiting*
Anaheim, California, 92801
United States
Recruiting Adam Lopez 714-778-1300
Sleep and Neuropsychiatry Centre *Recruiting*
Scarborough, Ontario, M1S 1T7
Canada
Recruiting Lana Romanov (416) 222-4594
Rush University Medical Center *Recruiting*
Chicago, Illinois, 60612-3833
United States
Recruiting Jennifer Kirkby 312-563-4292
Chest Medicine Associates, DBA Sleep Medicine Specialists *Recruiting*
Louisville, Kentucky, 40217
United States
Recruiting Pamela McCullough 502-479-1217
Sleep Disorder Centre *Recruiting*
Winnipeg, Manitoba, R2H 2A6
Canada
Recruiting Zoe Pouliot (204) 253-3678
CNS Research Institute *Recruiting*
Clementon, New Jersey, 08021
United States
Recruiting Annette Sciamanna 856-566-9000
Sleep Medicine of Middle Tennessee *Recruiting*
Nashville, Tennessee, 37205
United States
Recruiting Teresa King 615-385-1946
Pacific Sleep Medicine Services, Inc. *Recruiting*
Palm Springs, California, 92262
United States
Recruiting Glenna Knotts 760-416-3505
The Center for Sleep & Wake Disorders/Medwest Neurology *Recruiting*
Danville, Indiana, 46122
United States
Recruiting Carrie Doub 317-718-1403
Community Research Management Associates, Inc. *Recruiting*
Cincinnati, Ohio, 45219
United States
Recruiting Adam Roth 513-721-3868
Niagara Clinical Research *Recruiting*
Niagara Falls, Ontario, L2G 1J4
Canada
Recruiting Marion Plumley (905) 374-1405
Radiant Research - Atlanta West *Recruiting*
Austell, Georgia, 30106
United States
Recruiting Betsy Rambo 770-745-1404
Pulmonary Associates, PA *Recruiting*
Phoenix, Arizona, 85006
United States
Recruiting LiYi Fu 602-258-4951
HealthQuest Clinical Trials *Recruiting*
San Diego, California, 92123
United States
Recruiting Maricela Blythe 858-571-1188
Saint Vincent Mercy Medical Center - Sleep Disorders Center *Recruiting*
Toledo, Ohio, 43606
United States
Recruiting Mary McCormick 419-251-0591
Sleepmed, Inc. *Recruiting*
Macon, Georgia, 31201
United States
Recruiting Hope Kilgore 478-745-9050
Additional Information:
Study ID Numbers: C10953/3021/AP/MN;
Study Start Date: November 2003
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00078325
Other Sleep Apnea Syndromes Studies:
1. Behavioral Effects of Obstructive Sleep Apnea in Children
2. CEP-10953 in Treatment of Excessive Sleepiness Associated with Obstructive Sleep Apnea/Hypopnea (OSA/H) Syndrome
3. CEP-10953 for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder
Related Studies:
Other Sleep Apnea Syndromes Clinical Trials
Other Georgia Clinical Trials
Other Austell Clinical Trials
CEP-10953 in Treatment of Excessive Sleepiness Associated with Obstructive Sleep Apnea/Hypopnea (OSA/H) Syndrome
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