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The purpose of this study is to assess patient reported outcomes with armodafinil treatment in terms of improvement in sleepiness, satisfaction with treatment, impact on ability to engage in life activities (ie, daily or work and family and/or social activities), and effects on fatigue. Clinician ratings on patient response to armodafinil treatment will also be assessed.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Armodafinil | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Responders to the Patient Global Impression of Change (PGI-C) Ratings | A subjective measure (PGI-C rating) of the patient's global health, ie, a patient's rating of disease severity, as compared with a pretreatment (baseline) evaluation assessment by the patient using the Patient Global Impression of Severity of illness (PGI-S). Responders at each visit were defined as having at least minimal improvement in the severity of excessive sleepiness as compared with a pretreatment evaluation made using the PGI-S. | Weeks 4, 8, and 12, at 3 month intervals thereafter, and at a Final Visit (or last postbaseline observation). Evaluation continues until the Final Visit, which occurs when the product is commercially available or the marketing application is withdrawn. |
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Inclusion Criteria:
Exclusion Criteria:
Patients are excluded from participating in this study if any of the following criteria are met:
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| Name | Affiliation | Role |
|---|---|---|
| Sponsor's Medical Expert, MD | Cephalon | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sleep Disorders Center of Alabama | Birmingham | Alabama | 35213 | United States | ||
| Neurology Consultants of Tuscaloosa, P.C. |
1 female participant withdrew for noncompliance after randomization but prior to receiving study drug. The number of participants then analyzed (241) by a PGI-C rating was defined to be those participants who took at least 1 dose of study drug and had at least 1 postbaseline efficacy assessment (5 patients did not meet this requirement).
40 centers in the US. First participant enrolled: 5 October 2005. Last participant last visit: 27 July 2006
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| ID | Title | Description |
|---|---|---|
| FG000 | Armodafinil 150 to 250 mg/Day | Armodafinil 150 to 250 mg once daily in the morning |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Tuscaloosa |
| Alabama |
| 35406 |
| United States |
| Pulmonary Associates | Phoenix | Arizona | 85006 | United States |
| HOPE Research Institute | Phoenix | Arizona | 85032 | United States |
| PsyPharm Clinical Research | Phoenix | Arizona | 85050 | United States |
| PsyPharm Clinical Research Inc. | Tucson | Arizona | 85712 | United States |
| Neurology and Clinical Study Center | Little Rock | Arkansas | 72205 | United States |
| Advanced Clinical Research Institute | Anaheim | California | 92801 | United States |
| West Coast Clinical Trials, Inc | Long Beach | California | 90806 | United States |
| Neuro-Therapeutics, Inc | Pasadena | California | 91105 | United States |
| Penninsula Research Associates | Rolling Hills Estates | California | 90274 | United States |
| Pacific Sleep Program | San Francisco | California | 94109 | United States |
| The Sleep Disorders Center of Santa Barbara | Santa Barbara | California | 93103 | United States |
| Colorado Sleep Disorder Center | Englewood | Colorado | 80113 | United States |
| Clinical Research Group of St. Petersburg | St. Petersburg | Florida | 33707 | United States |
| Child Neurology Associates, PC | Atlanta | Georgia | 30342 | United States |
| Neurotrials, Inc. | Atlanta | Georgia | 30342 | United States |
| Sleepmed Inc. | Macon | Georgia | 31201 | United States |
| Savannah Neuurology | Savannah | Georgia | 31405 | United States |
| Evanston Northwestern Healthcare, Evanston Hospital | Evanston | Illinois | 60201 | United States |
| Convenant Clinic | Waterloo | Iowa | 50702 | United States |
| Chest Medicine Assocaites d/b/a/ Sleep Medicine Specialists | Louisville | Kentucky | 40217 | United States |
| Center for Sleep and Wake Disorders | Chevy Chase | Maryland | 20815 | United States |
| Neurocare. Inc | Newton | Massachusetts | 02459 | United States |
| Cumberland Research Associates | Fayetteville | North Carolina | 28304 | United States |
| Neurology and Neuro Science Associates | Akron | Ohio | 44302 | United States |
| North Coast Clinical Trials, Inc. | Beechwood | Ohio | 44122 | United States |
| Jonathan Schwartz | Oklahoma City | Oklahoma | 73109 | United States |
| Pacific Sleep Program | Portland | Oregon | 97209 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Crozer Chester Medical Center | Upland | Pennsylvania | 19013 | United States |
| University Services | West Chester | Pennsylvania | 19380 | United States |
| SleepMed of South Carolina | Columbia | South Carolina | 29201 | United States |
| Healthstar Physicians | Morristown | Tennessee | 37813 | United States |
| Sleep Medicine of Tennesse | Nashville | Tennessee | 37205 | United States |
| Metroplex Pulmonary and Sleep Center, PA | Allen | Texas | 75013 | United States |
| FutureSearch Trials | Austin | Texas | 78756 | United States |
| Sleep Medicine Associates of Texas, P.A | Plano | Texas | 75093 | United States |
| Texas Association of Pediatric Neurology | San Antonio | Texas | 78258 | United States |
| Vermont Medical Sleep Disorders Center | Essex Junction | Vermont | 05452 | United States |
| Sleep Disorders Center of the Mid Atlantic | Vienna | Virginia | 22182 | United States |
| Pacific Institute of Medical Science | Kirkland | Washington | 98034 | United States |
| Pacific Institute of Mental Health | Seattle | Washington | 98133 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Armodafinil 150 to 250 mg/Day | Armodafinil 150 to 250 mg once daily in the morning |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Categorical | 1 female participant withdrew for noncompliance after randomization but prior to receiving study drug | Number | participants |
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| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||||||||
| Gender | 1 female participant withdrew for noncompliance after randomization but prior to receiving study drug | Number | participants |
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| Region of Enrollment | Number | participants |
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| 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 | Number of Responders to the Patient Global Impression of Change (PGI-C) Ratings | A subjective measure (PGI-C rating) of the patient's global health, ie, a patient's rating of disease severity, as compared with a pretreatment (baseline) evaluation assessment by the patient using the Patient Global Impression of Severity of illness (PGI-S). Responders at each visit were defined as having at least minimal improvement in the severity of excessive sleepiness as compared with a pretreatment evaluation made using the PGI-S. | Posted | Number | Participants | Weeks 4, 8, and 12, at 3 month intervals thereafter, and at a Final Visit (or last postbaseline observation). Evaluation continues until the Final Visit, which occurs when the product is commercially available or the marketing application is withdrawn. |
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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 to 250 mg/Day | Armodafinil 150 to 250 mg once daily in the morning | 6 | 246 | 134 | 246 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Fetal growth retardation | Infections and infestations | Systematic Assessment |
| ||
| Iliac artery occlusion | Infections and infestations | Systematic Assessment |
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| Nasal abscess | Infections and infestations | Systematic Assessment |
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| Cellulitis | Infections and infestations | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sponsor's Medical Director, Clinical Research | Cephalon, Inc. | 1-877-237-4879 |
| ID | Term |
|---|---|
| D006970 | Disorders of Excessive Somnolence |
| D009290 | Narcolepsy |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077408 | Modafinil |
| ID | Term |
|---|---|
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Title | Measurements |
|---|---|
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