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| Sponsor: | Cephalon |
|---|---|
| Information provided by: | Cephalon |
| ClinicalTrials.gov Identifier: | NCT00711516 |
Purpose
The primary objective of this study is to determine whether treatment with armodafinil will provide improvements in prefrontal cortical activation in patients with OSAHS (Obstructive Sleep Apnea/Hypopnea Syndrome) who have residual sleepiness despite receiving nCPAP therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Excessive Sleepiness |
Drug: Armodafinil Drug: Placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Functional Neuroimaging Study of the Effects of Armodafinil (200 mg/Day) Treatment on Prefrontal Cortical Activation in Patients With Residual Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome |
| Enrollment: | 40 |
| Study Start Date: | September 2008 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Armodafinil treatment (200 mg/day)
|
Drug: Armodafinil
Armodafinil once-daily (50 mg/day (1 tablet) on Day 1; increased to 100 mg/day (2 tablets) starting on Day 2; increased to 150 mg/day (3 tablets) starting on Day 5; increased to 200 mg/day (4 tablets) starting on Day 8). Then continue 200 mg./day dosage through Day 14.
|
| 2: Placebo Comparator |
Drug: Placebo
Matching Placebo dosed once-daily (50 mg/day (1 tablet) on Day 1; increased to 100 mg/day (2 tablets) starting on Day 2; increased to 150 mg/day (3 tablets) starting on Day 5; increased to 200 mg/day (4 tablets) starting on Day 8). Then continue 200 mg./day dosage through Day 14.
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The Patient:
Contacts and Locations| United States, California | |
| VA San Diego Healthcare System | |
| San Diego, California, United States, 92161 | |
| Stanford University | |
| Stanford, California, United States, 94305 | |
| Peninsula Sleep Center | |
| Burlingame, California, United States, 94010 | |
| Pacific Research | |
| San Diego, California, United States, 92103 | |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical | |
| Boston, Massachusetts, United States, 12215 | |
| Neurocare, Inc. | |
| Newton, Massachusetts, United States, 02459 | |
| United States, Missouri | |
| Washington University | |
| St. Louis, Missouri, United States, 63108 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| Wake Research Associates | |
| Raleigh, North Carolina, United States, 27612 | |
| Study Director: | Sponsor's Medical Expert | Cephalon |
More Information
| Responsible Party: | Cephalon ( Sponsor's Medical Expert ) |
| Study ID Numbers: | C10953/4026/AP/US |
| Study First Received: | July 8, 2008 |
| Last Updated: | November 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00711516 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Apnea Syndromes Sleep Disorders Apnea Physiological Effects of Drugs Respiration Disorders Nervous System Diseases Dyssomnias Central Nervous System Stimulants |
Disorders of Excessive Somnolence Protective Agents Neuroprotective Agents Pharmacologic Actions Modafinil Respiratory Tract Diseases Mental Disorders Therapeutic Uses Central Nervous System Agents |