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The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment for patients with residual 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Armodafinil 150 mg/day |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Armodafinil 150 mg/day | Drug | Armodafinil 150 mg once daily in the morning |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maintenance of Wakefulness Test (MWT) | The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a subject to remain awake. Long latencies to sleep are indicative of a patient's ability to remain awake. The change from baseline in the mean sleep latency from the MWT (average of 4 tests at 0900, 1100, 1300, and 1500) was analyzed at weeks 4, 8, and 12. The primary efficacy variable was the mean change from the baseline assessment in MWT sleep latency as assessed at week 12 (or last post-baseline visit). | Change from baseline at 12 weeks or early termination |
| Number of Participants Who Had at Least Minimal Improvement in CGI-C Ratings at Week 12 or Last Post-baseline Visit. | Number of participants who had at least minimal improvement in CGI-C ratings at Week 12 or last post-baseline visit. The CGI-C uses the following categories and scoring assignments: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse. Severity of illness was assessed at baseline by the CGI-S, which consists of the following categories: 1=Normal (shows no signs of illness); 2=Borderline ill; 3=Mildly (Slightly) ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; and 7=Among the most extremely ill patients. | 12 weeks or last post-baseline visit |
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Diagnosis and Criteria for Inclusion: Patients are included in the study if all of the following criteria are met:
Written informed consent is obtained.
The patient is an outpatient, man or woman of any ethnic origin, 18 to 65 years of age (inclusive).
The patient has a complaint of excessive sleepiness despite nCPAP therapy being effective and being a regular user of nCPAP therapy.
The patient has a current diagnosis of OSAHS according to International Classification of Sleep Disorders (ICSD) criteria.
The patient meets the following nCPAP therapy requirements:
The patient is in good health as determined by a medical and psychiatric history, physical examination, ECG, and serum chemistry and hematology.
Women must be surgically sterile, 2 years postmenopausal, or, if of child bearing potential, using a medically accepted method of birth control (ie, barrier method with spermicide, steroidal contraceptive [oral, implanted, and Depo Provera contraceptives must be used in conjunction with a barrier method], or intrauterine device [IUD]) and agree to continued use of this method for the duration of the study.
The patient has a Clinical Global Impression of Severity of Illness (CGI S) rating of 4 or more.
The patient has an ESS score of 10 or more.
The patient does not have any medical or psychiatric disorders that could account for the excessive sleepiness.
The patient is able to complete self rating scales and computer based testing.
The patient is willing and able to comply with study restrictions and to attend regularly scheduled clinic visits as specified in this protocol.
Criteria for Exclusion: Patients are excluded from participating in this study if 1 or more of the following criteria are met:
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36 centers in the United States, France, Germany, Russia, and Australia. First participant enrolled: 26 March 2004/ Last participant last visit: 23 October 2004
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| ID | Title | Description |
|---|---|---|
| FG000 | Armodafinil 150 mg/Day | Armodafinil 150 mg once daily in the morning |
| FG001 | Placebo | Matching placebo tablets once daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Armodafinil 150 mg/Day | Armodafinil 150 mg once daily in the morning |
| BG001 | Placebo | Matching placebo tablets once daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Categorical | 4 male participants withdrew after randomization but prior to receiving study drug |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maintenance of Wakefulness Test (MWT) | The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a subject to remain awake. Long latencies to sleep are indicative of a patient's ability to remain awake. The change from baseline in the mean sleep latency from the MWT (average of 4 tests at 0900, 1100, 1300, and 1500) was analyzed at weeks 4, 8, and 12. The primary efficacy variable was the mean change from the baseline assessment in MWT sleep latency as assessed at week 12 (or last post-baseline visit). | Safety Analysis set of 259 total patients: 4 participants withdrew after randomization but prior to receiving study drug. Full Analysis set of 236 total patients: 23 patients that had withdrawn from the study were non-evaluable for efficacy. | Posted | Mean | Standard Deviation | Minutes | Change from baseline at 12 weeks or early termination |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Armodafinil 150 mg/Day | Armodafinil 150 mg once daily in the morning |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastro-oesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sponsor's Medical Director, Clinical Research | Cephalon | 1-877-237-4879 |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| D006970 | Disorders of Excessive Somnolence |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| D000077408 | Modafinil |
| ID | Term |
|---|---|
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Placebo |
| Drug |
Matching placebo tablets once daily |
|
| Lost to Follow-up |
|
| Physician Decision |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Miscellaneous |
|
| BG002 | Total | Total of all reporting groups |
| Number |
| participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Gender | 4 male participants withdrew after randomization but prior to receiving study drug | Number | participants |
|
| Region of Enrollment | Number | participants |
|
Armodafinil 150 mg once daily in the morning
| OG001 | Placebo | Matching placebo tablets once daily |
|
|
|
| Primary | Number of Participants Who Had at Least Minimal Improvement in CGI-C Ratings at Week 12 or Last Post-baseline Visit. | Number of participants who had at least minimal improvement in CGI-C ratings at Week 12 or last post-baseline visit. The CGI-C uses the following categories and scoring assignments: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse. Severity of illness was assessed at baseline by the CGI-S, which consists of the following categories: 1=Normal (shows no signs of illness); 2=Borderline ill; 3=Mildly (Slightly) ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; and 7=Among the most extremely ill patients. | Safety Analysis set of 259 total patients: 4 participants withdrew after randomization but prior to receiving study drug. Full Analysis set of 236 total patients: 23 patients that had withdrawn from the study were non-evaluable for efficacy. | Posted | Number | Participants | 12 weeks or last post-baseline visit |
|
|
|
|
| 0 |
| 129 |
| 22 |
| 129 |
| EG001 | Placebo | Matching placebo tablets once daily | 1 | 130 | 15 | 130 |
| Headache | Nervous system disorders | Systematic Assessment |
|
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| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |