|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Cephalon |
|---|---|
| Information provided by: | Cephalon |
| ClinicalTrials.gov Identifier: | NCT00078325 |
Purpose
The primary objective of this study is to determine whether treatment with Armodafinil (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 post-baseline visit.
| Condition | Intervention | Phase |
|---|---|---|
|
Obstructive Sleep Apnea Hypopnea |
Drug: Armodafinil 250 mg/day Drug: Armodafinil 150 mg/day Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A 12 Week, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CEP 10953 (150 and 250 mg/Day) as Treatment for Adults With Residual Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome |
| Enrollment: | 395 |
| Study Start Date: | February 2004 |
| Study Completion Date: | November 2004 |
| Primary Completion Date: | November 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Armodafinil 250 mg/day
|
Drug: Armodafinil 250 mg/day
Armodafinil 250 mg once daily in the morning
Other Names:
|
|
Experimental: 2
Armodafinil 150 mg/day
|
Drug: Armodafinil 150 mg/day
Armodafinil 150 mg once daily in the morning
Other Names:
|
|
Placebo Comparator: 3
Placebo
|
Drug: Placebo
Matching placebo tablets once daily in the morning
|
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
| ClinicalTrials.gov Identifier: | NCT00078325 History of Changes |
| Other Study ID Numbers: | C10953/3021/AP/MN |
| Study First Received: | February 23, 2004 |
| Results First Received: | June 1, 2009 |
| Last Updated: | July 6, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Excessive Sleepiness Obstructive Sleep Apnea Obstructive Sleep Hypopnea nCPAP |
Cephalon Cephalon, Inc NUVIGIL |
|
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders |
Nervous System Diseases Modafinil Central Nervous System Stimulants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Neuroprotective Agents Protective Agents |