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| Sponsor: | Cephalon |
|---|---|
| Information provided by: | Cephalon |
| ClinicalTrials.gov Identifier: | NCT00078325 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Sleep Apnea, Obstructive Sleep Apnea Syndromes |
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/Safety of CEP 10953 as Treatment for Adults With Residual Excessive Sleepiness Associated With OSA/H Syndrome |
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 meets 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
More Information
| Study ID Numbers: | C10953/3021/AP/MN |
| Study First Received: | February 23, 2004 |
| Last Updated: | January 12, 2006 |
| ClinicalTrials.gov Identifier: | NCT00078325 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Excessive Sleepiness Obstructive Sleep Apnea Obstructive Sleep Hypopnea nCPAP |
Cephalon Cephalon, Inc Nuvigil |
|
Sleep Apnea Syndromes Disease Apnea Sleep Apnea, Obstructive Respiration Disorders Nervous System Diseases Dyssomnias |
Sleep Disorders Sleep Disorders, Intrinsic Signs and Symptoms Pathologic Processes Respiratory Tract Diseases Syndrome Signs and Symptoms, Respiratory |