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Sponsored by: |
Cephalon |
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Information provided by: | Cephalon |
ClinicalTrials.gov Identifier: | NCT00080288 |
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 chronic shift work sleep disorder (SWSD) by measuring mean sleep latency from the Multiple Sleep Latency Test (MSLT) (20 minutes) and by Clinical Global Impression of Change (CGI C) ratings (for sleepiness during night shifts including the commute to and from work) at week 12 (or last postbaseline visit).
Condition | Intervention | Phase |
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Excessive Sleepiness Shift Work Sleep Disorder |
Drug: CEP-10953 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 12 Week, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CEP 10953 as Treatment for Adults With Excessive Sleepiness Associated With Chronic SWSD |
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 ID Numbers: | C10953/3022/CM/MN |
Study First Received: | March 25, 2004 |
Last Updated: | January 12, 2006 |
ClinicalTrials.gov Identifier: | NCT00080288 |
Health Authority: | United States: Food and Drug Administration |
Excessive Sleepiness Chronic Shift Work Sleep Disorder Chronic SWSD Circadian Rhythm Disorder |
Shift Worker Cephalon Cephalon, Inc Nuvigil |
Signs and Symptoms Sleep Disorders, Circadian Rhythm Mental Disorders Neurologic Manifestations Disorders of Environmental Origin |
Dyssomnias Sleep Disorders Occupational Diseases Chronobiology Disorders Arrhythmias, Cardiac |
Nervous System Diseases |