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CEP-10953 for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on CEP-10953 for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. CEP-10953 for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder Clinical research trials and CEP-10953 for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder healthcare trials occur in a lot of of places across 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 effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including CEP-10953 for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder. CEP-10953 for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a CEP-10953 for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder clinical trial. Test subjects typically receive the most effective healthcare possible for their CEP-10953 for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > CEP-10953 for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder  CEP-10953 for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder
CEP-10953 for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder
For Condition: Sleep Apnea Syndromes,Sleep Apnea, Obstructive,Shift-Work Sleep Disorder,Narcolepsy
Status: Recruiting
Sponsor(s): Cephalon ,
Synopsis: The primary objective of this study is to evaluate the safety and tolerability of CEP-10953 administered on a flexible-dosage regimen of 100 to 250 mg/day for up to 12 months to patients with excessive sleepiness associated with a current diagnisis of narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS)(regular users of nasal continuous positive airway pressure [nCPAP] therapy), or chronic shift work sleep disorder (SWSD). Safety and tolerability will be evaluated throughout the study through adverse event data, clinical laboratory test evaluations, vital sign measurements, electrocardiography, and physical examination findings.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, 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) Men and women (outpatients) of any ethnic origin, between 18 and 65 years of age (inclusive) are eligible. (c) The patient has a complaint of excessive sleepiness associated with a current diagnosis of: - Narcolepsy–Diagnosis made on the basis of International Classification of Sleep Disorders (ICSD) (American Sleep Disorders Association 2000) criteria. - OSAHS–Diagnosis made on the basis of ICSD criteria. Furthermore, patients with OSAHS must meet the following nCPAP therapy requirements: • Previous 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 effective, in the opinion of the investigator. • Evidence of regular nCPAP usage must be shown during a 2 week evaluation period (ie, nCPAP therapy usage of at least 4 hours/night on at least 70% of the nights). - Chronic SWSD–Diagnosis made on the basis of at least minimum ICSD criteria. Furthermore, patients with chronic SWSD must have had excessive sleepiness during night shifts for at least 3 months, work a minimum of 3 night shifts per month that include at least 6 hours between 2200 and 0800 and are no longer than 12 hours in duration, and plan to continue to work night shifts throughout the study. (d) The patient has a Clinical Global Impression of Severity of Disease (CGI-S) rating of 4 or more. (For patients with OSAHS, the CGI-S scale will be administered after nCPAP effectiveness and regular usage is established. For patients with narcolepsy or OSAHS, CGI-S will be evaluated to assess general clinical condition. For patients with SWSD, CGI-S will be evaluated to assess sleepiness during the night shift including the commute to and from work.) (e) The patient is in good health as determined by a medical and psychiatric history, medical examination, electrocardiogram (ECG), serum chemistry and hematology. Women must be surgically sterile, 2 years postmenopausal, or if of childbearing potential, must use 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]). (f) The patient may have been prescribed PROVIGIL or stimulant therapy to treat the sleep disorder; however, they must have undergone a washout period of at least 7 days prior to screening assessments. (g) The patient must be 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) have any clinically significant, uncontrolled medical conditions (treated or untreated) (b) have a probable diagnosis of a current sleep disorder other than the primary diagnosis of narcolepsy, OSAHS, or chronic SWSD (c) consume caffeine including coffee, tea and/or other caffeine containing beverages or food averaging more than 600 mg of caffeine or more than 8 cups of coffee 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 baseline visit (e) have a history of alcohol, narcotic, or any other drug abuse as defined by the Diagnostic and Statistical Manual of the American Psychiatric Association, 4th Edition (DSM IV) (f) have a positive UDS at the screening visit (g) have a clinically significant deviation from normal in the physical examination (h) are pregnant or lactating. Any woman becoming pregnant during the study will be withdrawn from the study (i) have used an investigational drug within 1 month before the screening visit (j) have any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery) (k) have a known clinically significant drug sensitivity to stimulants
Total Enrollment: 300
Location and Contact Information:
Pharmacology Research Institute *Recruiting*
Los Alamitos, California, 90720
United States
Recruiting Judy Morrissey 714-827-3667
Radiant Research - Tucson *Recruiting*
Tucson, Arizona, 85710
United States
Recruiting Louise Strehlow 520-885-6793
Bay Area Research Institute *Recruiting*
Lafayette, California, 94549
United States
Recruiting Berry Shepherd 925-283-9006
Clinic of Neurology and Neurosurgery of Saint Petersburg *Recruiting*
Saint Petersburg, , 197 022
Russian Federation
Recruiting Alexander Skoromets +7-812-234 16 25
Cardioclinic *Recruiting*
Saint Petersburg, , 196 128
Russian Federation
Recruiting Vyacheslav Merkulov +7-812-388 81-43
NeuroTrials Research of New Orleans, LLC *Recruiting*
Metairie, Louisiana, 70001
United States
Recruiting Tim Gagliano 504-780-2550
North Coast Clinical Trials, Inc *Recruiting*
Beachwood, Ohio, 44122
United States
Recruiting Catherine Boyer 216-514-1803
Institute of Pulmonology *Recruiting*
Moscow, , 105 077
Russian Federation
Recruiting Sergey Babak +7-95-465 52 64
Arkansas Center for Sleep Medicine *Recruiting*
Little Rock, Arkansas, 72205
United States
Recruiting Bill Olds 501-661-9191
Marc Raphaelson, MD, PA *Recruiting*
Frederick, Maryland, 21702
United States
Recruiting Marcia Goodrich 301-698-5606
Somnos Laboratories, Inc *Recruiting*
Lincoln, Nebraska, 68510
United States
Recruiting T. Stentz 402-486-3410
United Hospital and Out-patient Clinic of Presidential Medical Center of Russian Federation *Recruiting*
Moscow, , 119 285
Russian Federation
Recruiting Alexander Belov +7-95-143 98 95
Central Phoenix Medical Clinic, LLC *Recruiting*
Phoenix, Arizona, 85014
United States
Recruiting Mario Mendivil 602-200-3814
CNS Research Institute, PC *Recruiting*
Clementon, New Jersey, 08021
United States
Recruiting Annette Sciamanna 856-566-9000
Clinic of Neurology and Neurosurgery of Saint Petersburg *Recruiting*
Saint Petersburg, , 197 022
Russian Federation
Recruiting Alexander Skoromets +7-812-234 16 25
Therafirst Medical Centers *Recruiting*
Ft. Lauderdale, Florida, 33308
United States
Recruiting Helena Kosters 954-564-4326
Renstar Medical Research *Recruiting*
Ocala, Florida, 34471
United States
Recruiting Pat Marotta 352-629-5800
Precision Research *Recruiting*
Hallandale, Florida, 33009
United States
Recruiting Joy Hilliker 954-456-1997
Herron Medical Center, Ltd. *Recruiting*
Chicago, Illinois, 60610
United States
Recruiting Stephen Herron 312-337-6072
Radiant Research, Boise *Recruiting*
Boise, Idaho, 83704
United States
Recruiting Chris Brucks 208-377-8931
Long Island Clinical Research Associates, LLP *Recruiting*
Great Neck, New York, 11021
United States
Recruiting Andrew Mulchinski 516-466-1051
Wake Forest University Health Sciences *Recruiting*
Winston Salem, North Carolina, 27157
United States
Recruiting Barbara Lasater 336-716-9234
Cardioclinic *Recruiting*
Saint Petersburg, , 196 128
Russian Federation
Recruiting Vyacheslav Merkulov +7-812-388 81-43
Medical Sanitary Unit No. 122 of Saint-Petersburg *Recruiting*
Saint-Petersburg, , 194 291
Russian Federation
Recruiting Olga Chizhova +7-812-559 94 57
IPS Research Company *Recruiting*
Oklahoma City, Oklahoma, 73103
United States
Recruiting Adele White 405-235-8188
City Clinical Hospital No. 81 *Recruiting*
Moscow, , 127 644
Russian Federation
Recruiting Olga Lubshina 7 095 483 3392
City Clinical Hospital No. 81 *Recruiting*
Moscow, , 127 644
Russian Federation
Recruiting Olga Lubshina 7 095 483 3392
Rocky Mountain Center for Clinical Research *Recruiting*
Wheat Ridge, Colorado, 80033
United States
Recruiting Ann Muldrow 303-403-8478
Radiant Research, San Antonio *Recruiting*
San Antonio, Texas, 78229
United States
Recruiting Patricia Suwal 210-614-7483
Institute of Pulmonology *Recruiting*
Moscow, , 105 077
Russian Federation
Recruiting Sergey Babak +7-95-465 52 64
Center of Rehabilitation of Presidential Medical Center *Recruiting*
Moscow region, , 143 088
Russian Federation
Recruiting Dimitriy Kallistov +7-95-992 13 36
Radiant Research Alexian Brothers *Recruiting*
Elk Grove Village, Illinois, 60007
United States
Recruiting Sania Hamilton 847-640-9908
Northwest Clinical Research Center *Recruiting*
Bellevue, Washington, 98004
United States
Recruiting Elizabeth Mann 425-453-0404
Pivotal Research Centers *Recruiting*
Peoria, Arizona, 85381
United States
Recruiting Sherepta Chroninger 623-815-9714
Lehigh Valley Hospital Hospital *Recruiting*
Allentown, Pennsylvania, 18105
United States
Recruiting Michelle Rummel 610-402-1870
Anderson Clinical Research *Recruiting*
Redlands, California, 92374
United States
Recruiting Karen Michael 909-792-9007
Neuro-Therapeutics Inc. *Recruiting*
Pasadena, California, 91105
United States
Recruiting Donna Sider 626-356-0800
Radiant Research, Chicago *Recruiting*
Chicago, Illinois, 60610
United States
Recruiting Anne Kelleher 312-494-2316
Synergy Clinical Research Center *Recruiting*
San Diego, California, 92105
United States
Recruiting Mohammed Bari 619-326-7420
Michigan Head-Pain Neurological Institute *Recruiting*
Ann Arbor, Michigan, 48104
United States
Recruiting Marjorie Winters 743-677-6000
Oregon Health and Science University *Recruiting*
Portland, Oregon, 97239
United States
Recruiting Meredith Dunn 503-418-4679
Additional Information:
Study ID Numbers: C10953/3023/ES/MN;
Study Start Date: November 2003
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00078312
Other Sleep Apnea Syndromes Studies:
1. CEP-10953 for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder
2. CEP-10953 in Treatment of Excessive Sleepiness Associated with Obstructive Sleep Apnea/Hypopnea (OSA/H) Syndrome
3. Behavioral Effects of Obstructive Sleep Apnea in Children
Related Studies:
Other Sleep Apnea Syndromes Clinical Trials
Other Clinical Trials
Other Saint-Petersburg Clinical Trials
CEP-10953 for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder
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