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Sponsored by: |
Cephalon |
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Information provided by: | Cephalon |
ClinicalTrials.gov Identifier: | NCT00228553 |
A 12 Month, Open-Label, Flexible Dosage Extension Study of the Safety and Efficacy of CEP-10953 in the Treatment of Patients with Excessive Sleepiness Associated with Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder
Condition | Intervention | Phase |
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Excessive Daytime Sleepiness Narcolepsy |
Drug: CEP-10953 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Placebo Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | A 12 Month, Open-Label, Flexible Dosage Extension Study of the Safety and Efficacy of CEP-10953 in the Treatment of Patients With Excessive Sleepiness Associated With Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder |
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:
Exclusion Criteria:
Patients are excluded from participating in this study if 1 or more of the following criteria are met:
Study Director: | Gwendolyn Niebler, DO | Cephalon |
Study ID Numbers: | C10953/3024/ES/MN |
Study First Received: | September 27, 2005 |
Last Updated: | November 9, 2007 |
ClinicalTrials.gov Identifier: | NCT00228553 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Sleep Apnea Syndromes Sleep Disorders, Circadian Rhythm Apnea Sleep Apnea, Obstructive Sleep Disorders Dyssomnias Disorders of Environmental Origin |
Chronobiology Disorders Disorders of Excessive Somnolence Sleep Disorders, Intrinsic Narcolepsy Mental Disorders Gelineau's Syndrome Occupational Diseases |
Sleep Disorders, Circadian Rhythm Mental Disorders Narcolepsy Nervous System Diseases Disorders of Environmental Origin Sleep Disorders |
Dyssomnias Occupational Diseases Chronobiology Disorders Disorders of Excessive Somnolence Sleep Disorders, Intrinsic |