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The primary objective of this study is to evaluate the safety and tolerability of Armodafinil (CEP-10953) administered on a flexible-dosage regimen of 100 to 250 mg/day for up to 12 months to patients with excessive sleepiness associated with a current diagnosis of narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS)(regular users of nasal continuous positive airway pressure [nCPAP] therapy), or chronic shift work sleep disorder (SWSD).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CEP-10953 (Armodafinil) | Drug | Armodafinil (po) 100 to 250 mg/day up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability as Measured by Number of Participants With Adverse Events | Serious and Non-serious Adverse Events (SAEs). Serious adverse event is any adverse event occurring at any dose that results in any of the following outcomes: death, life-threatening, inpatient hospitalization, persistent or significant disability, congenital anomaly, or an important medical event. An adverse event that does not meet any of the criteria for seriousness listed previously will be regarded as a nonserious adverse event. | Screening/Baseline and months 1, 3, 6, 9, and 12 and every 3 months thereafter |
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Inclusion Criteria:
Patients are included in the study if all of the following criteria are met:
Written informed consent is obtained.
Men and women (outpatients) of any ethnic origin, between 18 and 65 years of age (inclusive) are eligible.
The patient has a complaint of excessive sleepiness associated with a current diagnosis of:
Narcolepsy-Diagnosis made on the basis of International Classification of Sleep Disorders (ICSD) (American Sleep Disorders Association 2000) criteria.
OSAHS-Diagnosis made on the basis of ICSD criteria. Furthermore, patients with OSAHS must meet the following nCPAP therapy requirements:
Chronic SWSD-Diagnosis made on the basis of at least minimum ICSD criteria. Furthermore, patients with chronic SWSD must have had excessive sleepiness during night shifts for at least 3 months, work a minimum of 3 night shifts per month that include at least 6 hours between 2200 and 0800 and are no longer than 12 hours in duration, and plan to continue to work night shifts throughout the study.
The patient has a Clinical Global Impression of Severity of Disease (CGI-S) rating of 4 or more. (For patients with OSAHS, the CGI-S scale will be administered after nCPAP effectiveness and regular usage is established. For patients with narcolepsy or OSAHS, CGI-S will be evaluated to assess general clinical condition. For patients with SWSD, CGI-S will be evaluated to assess sleepiness during the night shift including the commute to and from work.)
The patient is in good health as determined by a medical and psychiatric history, medical examination, electrocardiogram (ECG), serum chemistry and hematology. Women must be surgically sterile, 2 years postmenopausal, or if of childbearing potential, must use 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]).
The patient may have been prescribed PROVIGIL or stimulant therapy to treat the sleep disorder; however, they must have undergone a washout period of at least 7 days prior to screening assessments.
The patient must be willing and able to comply with study restrictions and to attend regularly scheduled clinic visits as specified in this protocol.
Exclusion Criteria:
Patients are excluded from participating in this study if 1 or more of the following criteria are met:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pivotal Research Centers | Peoria | Arizona | 85381 | United States | ||
| Central Phoenix Medical Clinic, LLC |
5 male participants withdrew after enrollment but prior to receiving study drug (1 withdrew consent, 3 were lost to follow-up, and 1 was noncompliant). These 5 patients are in the participant flow, but not in the safety data set since they did not receive study drug.
41 centers (US 34, Russia 7). First patient enrolled: 30 January 2004/ Last patient last visit: 19 July 2006
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| ID | Title | Description |
|---|---|---|
| FG000 | Armodafinil 100 to 250 mg/Day | Participants with narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS): armodafinil once daily in the morning. Participants with chronic Shift Work Sleep Disorder (SWSD): armodafinil 100-250 mg once daily only on nights worked |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Phoenix |
| Arizona |
| 85014 |
| United States |
| Radiant Research - Tucson | Tucson | Arizona | 85710 | United States |
| Central Arkansas Research | Hot Springs | Arkansas | 71913 | United States |
| Arkansas Center for Sleep Medicine | Little Rock | Arkansas | 72205 | United States |
| Bay Area Research Institute | Lafayette | California | 94549 | United States |
| Pharmacology Research Institute | Los Alamitos | California | 90720 | United States |
| Neuro-Therapeutics Inc. | Pasadena | California | 91105 | United States |
| Anderson Clinical Research | Redlands | California | 92374 | United States |
| Synergy Clinical Research Center | San Diego | California | 92105 | United States |
| BMR HealthQuest Clinical Trials | San Diego | California | 92123 | United States |
| Rocky Mountain Center for Clinical Research | Wheat Ridge | Colorado | 80033 | United States |
| Therafirst Medical Centers | Fort Lauderdale | Florida | 33308 | United States |
| Precision Research | Hallandale | Florida | 33009 | United States |
| Renstar Medical Research | Ocala | Florida | 34471 | United States |
| Clinical Research Group of St. Petersburg | St. Petersburg | Florida | 33707 | United States |
| Radiant Research, Boise | Boise | Idaho | 83704 | United States |
| Herron Medical Center, Ltd. | Chicago | Illinois | 60610 | United States |
| Radiant Research, Chicago | Chicago | Illinois | 60610 | United States |
| Radiant Research Alexian Brothers | Elk Grove Village | Illinois | 60007 | United States |
| Henry W. Lahmeyer, MD and Associates | Northfield | Illinois | 60093 | United States |
| Vince and Associates Clinical Research | Overland Park | Kansas | 66211 | United States |
| NeuroTrials Research of New Orleans, LLC | Metairie | Louisiana | 70001 | United States |
| Marc Raphaelson, MD, PA | Frederick | Maryland | 21702 | United States |
| Michigan Head-Pain Neurological Institute | Ann Arbor | Michigan | 48104 | United States |
| Somnos Laboratories, Inc | Lincoln | Nebraska | 68510 | United States |
| Clinical Research Center of Nevada | Las Vegas | Nevada | 89104 | United States |
| CNS Research Institute, PC | Clementon | New Jersey | 08021 | United States |
| Long Island Clinical Research Associates, LLP | Great Neck | New York | 11021 | United States |
| North Shore University Hospital | Manhasset | New York | 11030 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| North Coast Clinical Trials, Inc | Beachwood | Ohio | 44122 | United States |
| IPS Research Company | Oklahoma City | Oklahoma | 73103 | United States |
| Clinical Research Studies | Oklahoma City | Oklahoma | 73109 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Lehigh Valley Hospital Hospital | Allentown | Pennsylvania | 18105 | United States |
| Center for Sleep Disorders, Inc. | Pottstown | Pennsylvania | 19464 | United States |
| SleepMed of South Carolina | Columbia | South Carolina | 29201 | United States |
| Radiant Research, San Antonio | San Antonio | Texas | 78229 | United States |
| Radiant Research | Salt Lake City | Utah | 84107 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98004 | United States |
| Institute of Pulmonology | Moscow | 105 077 | Russia |
| Moscow City Somnological Center | Moscow | 107 014 | Russia |
| City Clinical Hospital No. 83 | Moscow | 115 682 | Russia |
| United Hospital and Out-patient Clinic of Presidential Medical Center of Russian Federation | Moscow | 119 285 | Russia |
| City Clinical Hospital No. 81 | Moscow | 127 644 | Russia |
| Center of Rehabilitation of Presidential Medical Center | Moscow | 143 088 | Russia |
| Medical Sanitary Unit No. 122 of Saint-Petersburg | Saint Petersburg | 194 291 | Russia |
| Cardioclinic | Saint Petersburg | 196 128 | Russia |
| Clinic of Neurology and Neurosurgery of Saint Petersburg | Saint Petersburg | 197 022 | Russia |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Armodafinil 100 to 250 mg/Day | Participants with narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS): armodafinil once daily in the morning. Participants with chronic Shift Work Sleep Disorder (SWSD): armodafinil 100-250 mg once daily only on nights worked |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Gender | 5 male participants withdrew after enrollment but prior to receiving study drug (1 withdrew consent, 3 were lost to follow-up, and 1 was noncompliant) | Number | participants |
| ||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Safety and Tolerability as Measured by Number of Participants With Adverse Events | Serious and Non-serious Adverse Events (SAEs). Serious adverse event is any adverse event occurring at any dose that results in any of the following outcomes: death, life-threatening, inpatient hospitalization, persistent or significant disability, congenital anomaly, or an important medical event. An adverse event that does not meet any of the criteria for seriousness listed previously will be regarded as a nonserious adverse event. | Safety Analysis set of 323 total patients: 5 participants withdrew after enrollment but prior to receiving study drug (1 withdrew consent, 3 were lost to follow-up, and 1 was noncompliant) | Posted | Number | Participants | Screening/Baseline and months 1, 3, 6, 9, and 12 and every 3 months thereafter |
|
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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 100 to 250 mg/Day | Participants with narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS): armodafinil once daily in the morning. Participants with chronic Shift Work Sleep Disorder (SWSD): armodafinil 100-250 mg once daily only on nights worked | 12 | 323 | 177 | 323 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Tachycardia paroxysmal | Cardiac disorders | Systematic Assessment |
| ||
| Abdominal haematoma | Gastrointestinal disorders | Systematic Assessment |
| ||
| Chest pain | General disorders | Systematic Assessment |
| ||
| Non-cardiac chest pain | General disorders | Systematic Assessment |
| ||
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Multiple sclerosis | Nervous system disorders | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Nephrolithiasis | Renal and urinary disorders | Systematic Assessment |
| ||
| Menometrorrhagia | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Chronic obstructive airways disease exacerbated | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Haematoma | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Sinusitis | Infections and infestations | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sponsor's Medical Director, Clinical Research | Cephalon | 1-877-237-4879 |
| ID | Term |
|---|---|
| D009290 | Narcolepsy |
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| D020178 | Sleep Disorders, Circadian Rhythm |
| D006970 | Disorders of Excessive Somnolence |
| D002385 | Cataplexy |
| D021081 | Chronobiology Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D009784 | Occupational 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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