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| Sponsor: | Cephalon |
|---|---|
| Information provided by: | Cephalon |
| ClinicalTrials.gov Identifier: | NCT00078312 |
Purpose
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 diagnosis 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Narcolepsy Sleep Apnea, Obstructive Sleep Apnea Syndromes Shift-Work Sleep Disorder |
Drug: CEP-10953 |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A 12-Month, Open Label, Flexible-Dosage Study of the Safety/Efficacy of CEP 10953 in the Treatment of Excessive Sleepiness Associated With Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients are included in the study if all of the following criteria are met:
The patient has a complaint of excessive sleepiness associated with a current diagnosis of:
OSAHS-Diagnosis made on the basis of ICSD criteria. Furthermore, patients with OSAHS must meet the following nCPAP therapy requirements:
Exclusion Criteria:
Patients are excluded from participating in this study if 1 or more of the following criteria are met:
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Pivotal Research Centers | |
| Peoria, Arizona, United States, 85381 | |
| Central Phoenix Medical Clinic, LLC | |
| Phoenix, Arizona, United States, 85014 | |
| Radiant Research - Tucson | |
| Tucson, Arizona, United States, 85710 | |
| United States, Arkansas | |
| Arkansas Center for Sleep Medicine | |
| Little Rock, Arkansas, United States, 72205 | |
| Central Arkansas Research | |
| Hot Springs, Arkansas, United States, 71913 | |
| United States, California | |
| Anderson Clinical Research | |
| Redlands, California, United States, 92374 | |
| Bay Area Research Institute | |
| Lafayette, California, United States, 94549 | |
| Synergy Clinical Research Center | |
| San Diego, California, United States, 92105 | |
| Pharmacology Research Institute | |
| Los Alamitos, California, United States, 90720 | |
| Neuro-Therapeutics Inc. | |
| Pasadena, California, United States, 91105 | |
| BMR HealthQuest Clinical Trials | |
| San Diego, California, United States, 92123 | |
| United States, Colorado | |
| Rocky Mountain Center for Clinical Research | |
| Wheat Ridge, Colorado, United States, 80033 | |
| United States, Florida | |
| Therafirst Medical Centers | |
| Ft. Lauderdale, Florida, United States, 33308 | |
| Renstar Medical Research | |
| Ocala, Florida, United States, 34471 | |
| Precision Research | |
| Hallandale, Florida, United States, 33009 | |
| Clinical Research Group of St. Petersburg | |
| St. Petersburg, Florida, United States, 33707 | |
| United States, Idaho | |
| Radiant Research, Boise | |
| Boise, Idaho, United States, 83704 | |
| United States, Illinois | |
| Radiant Research, Chicago | |
| Chicago, Illinois, United States, 60610 | |
| Radiant Research Alexian Brothers | |
| Elk Grove Village, Illinois, United States, 60007 | |
| Herron Medical Center, Ltd. | |
| Chicago, Illinois, United States, 60610 | |
| Henry W. Lahmeyer, MD and Associates | |
| Northfield, Illinois, United States, 60093 | |
| United States, Kansas | |
| Vince and Associates Clinical Research | |
| Overland Park, Kansas, United States, 66211 | |
| United States, Louisiana | |
| NeuroTrials Research of New Orleans, LLC | |
| Metairie, Louisiana, United States, 70001 | |
| United States, Maryland | |
| Marc Raphaelson, MD, PA | |
| Frederick, Maryland, United States, 21702 | |
| United States, Michigan | |
| Michigan Head-Pain Neurological Institute | |
| Ann Arbor, Michigan, United States, 48104 | |
| United States, Nebraska | |
| Somnos Laboratories, Inc | |
| Lincoln, Nebraska, United States, 68510 | |
| United States, Nevada | |
| Clinical Research Center of Nevada | |
| Las Vegas, Nevada, United States, 89104 | |
| United States, New Jersey | |
| CNS Research Institute, PC | |
| Clementon, New Jersey, United States, 08021 | |
| United States, New York | |
| Long Island Clinical Research Associates, LLP | |
| Great Neck, New York, United States, 11021 | |
| North Shore University Hospital | |
| Manhasset, New York, United States, 11030 | |
| United States, North Carolina | |
| Wake Forest University Health Sciences | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Ohio | |
| North Coast Clinical Trials, Inc | |
| Beachwood, Ohio, United States, 44122 | |
| United States, Oklahoma | |
| IPS Research Company | |
| Oklahoma City, Oklahoma, United States, 73103 | |
| Clinical Research Studies | |
| Oklahoma City, Oklahoma, United States, 73109 | |
| United States, Oregon | |
| Oregon Health and Science University | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| Lehigh Valley Hospital Hospital | |
| Allentown, Pennsylvania, United States, 18105 | |
| Center for Sleep Disorders, Inc. | |
| Pottstown, Pennsylvania, United States, 19464 | |
| United States, South Carolina | |
| SleepMed of South Carolina | |
| Columbia, South Carolina, United States, 29201 | |
| United States, Texas | |
| Radiant Research, San Antonio | |
| San Antonio, Texas, United States, 78229 | |
| United States, Utah | |
| Radiant Research | |
| Salt Lake City, Utah, United States, 84107 | |
| United States, Washington | |
| Northwest Clinical Research Center | |
| Bellevue, Washington, United States, 98004 | |
| Russian Federation | |
| Clinic of Neurology and Neurosurgery of Saint Petersburg | |
| Saint Petersburg, Russian Federation, 197 022 | |
| Institute of Pulmonology | |
| Moscow, Russian Federation, 105 077 | |
| Cardioclinic | |
| Saint Petersburg, Russian Federation, 196 128 | |
| City Clinical Hospital No. 81 | |
| Moscow, Russian Federation, 127 644 | |
| Moscow City Somnological Center | |
| Moscow, Russian Federation, 107 014 | |
| United Hospital and Out-patient Clinic of Presidential Medical Center of Russian Federation | |
| Moscow, Russian Federation, 119 285 | |
| Institute of Pulmonology | |
| Moscow, Russian Federation, 105 077 | |
| Center of Rehabilitation of Presidential Medical Center | |
| Moscow, Russian Federation, 143 088 | |
| City Clinical Hospital No. 83 | |
| Moscow, Russian Federation, 115 682 | |
| Medical Sanitary Unit No. 122 of Saint-Petersburg | |
| Saint-Petersburg, Russian Federation, 194 291 | |
More Information
| Study ID Numbers: | C10953/3023/ES/MN |
| Study First Received: | February 23, 2004 |
| Last Updated: | September 7, 2007 |
| ClinicalTrials.gov Identifier: | NCT00078312 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Excessive Sleepiness Narcolepsy Cataplexy Sleep Attacks Obstructive Sleep Apnea Obstructive Sleep Hypopnea nCPAP |
Chronic Shift Work Sleep Disorder Chronic SWSD Circadian Rhythm Disorder Shift Worker Cepahlon Cephalon, Inc Nuvigil |
|
Sleep Apnea Syndromes Disease Sleep Disorders, Circadian Rhythm Apnea Nervous System Diseases Sleep Apnea, Obstructive Respiration Disorders Disorders of Environmental Origin Dyssomnias Sleep Disorders Chronobiology Disorders |
Disorders of Excessive Somnolence Sleep Disorders, Intrinsic Signs and Symptoms Pathologic Processes Respiratory Tract Diseases Mental Disorders Narcolepsy Syndrome Neurologic Manifestations Signs and Symptoms, Respiratory Occupational Diseases |