Efficacy and Tolerability of Armodafinil in Adults With Excessive Sleepiness Associated With Shift Work Disorder
- Registration Number
- NCT01080807
- Lead Sponsor
- Cephalon
- Brief Summary
The primary objective of the study is to determine whether armodafinil treatment is more effective than placebo treatment in patients with excessive sleepiness associated with shift work disorder (SWD) by measuring improved clinical condition late in the shift, including the commute home.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 385
- The patient currently meets the criteria for Shift Work Disorder (SWD) for duration of at least 1 month.
- The patient has the presence of excessive sleepiness late in the shift, including the commute home if applicable, with a Clinical Global Impression of Severity of Illness (CGI-S) rating of 4 or more at screening.
- The patient has clinically significant difficulty in social or occupational functioning, with a Global Assessment of Function (GAF) score less than 70 (on clinician interview) at screening.
- The patient has a Karolinska Sleepiness Scale (KSS) score of 6 or more at screening (visit 1) that is confirmed at baseline (visit 2).
- The patient works at least 5 night shifts per month, of which at least 3 nights are consecutive, and plans to maintain this schedule.
- The patient works night shifts or rotating shifts that include at least 6 hours between 2200 and 0800 (including the time period 0400 to 0800), and shifts are no longer than 12 hours in duration.
- The patient is in good health, as judged by the investigator.
- The patient is able to complete self-rating scales.
- Women of childbearing potential (not surgically sterile or 2 years postmenopausal), must use a medically accepted method of contraception, and must continue use of 1 of these methods for the duration of the study (and for 30 days after participation in the study). Acceptable methods of contraception include: abstinence, barrier method with spermicide, steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method, or intrauterine device (IUD).
- The patient is willing and able to comply with study restrictions and to attend regularly scheduled clinic visits as specified in this protocol
- The patient has mild or more severe obstructive sleep apnea (OSA) defined as an apnea/hypopnea index more than 5 as determined by daytime polysomnography (PSG).
- The patient has a medical or psychiatric disorder causing clinically significant functional impairment or contributing to the patient's excessive sleepiness.
- The patient is currently taking a medication or substance that is causing clinically significant functional impairment or contributing to the patient's excessive sleepiness.
- The patient has a clinically significant treated or untreated medical condition.
- The patient has a history of clinically significant suicidal ideation in the judgment of the principal investigator or is currently suicidal based on medical and psychiatric history.
- The patient has a known hypersensitivity to armodafinil, racemic modafinil, or any component of the study drug tablets.
- The patient has a history of any clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction, including multiple allergies or drug reactions.
- The patient consumes caffeine including coffee, tea and/or other caffeine containing beverages or food averaging more than 600 mg of caffeine per day within 7 days of the baseline visit.
- The patient uses any prescription or over-the-counter (OTC) drugs disallowed by the protocol within 30 days of the baseline visit.
- The patient has been in a prior armodafinil study.
- The patient has a history of alcohol, narcotic, or any other drug abuse.
- The patient has a positive urine drug screen (UDS) without medical explanation at the screening visit.
- The patient has a clinically significant deviation from normal on physical examination.
- The patient is a pregnant or lactating woman.
- The patient has used an investigational drug within 1 month of the screening visit.
- The patient has a disorder that could interfere with the absorption, distribution, metabolism, or excretion of the investigational product.
- The patient needs to use any of the excluded medications in this protocol.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 150 mg/day armodafinil Armodafinil - Matching placebo Matching Placebo -
- Primary Outcome Measures
Name Time Method Percentage of Patients With at Least Minimal Improvement From Baseline in the Clinical Global Impression of Change (CGI-C) Rating as Related to Late Shift Sleepiness at Endpoint Baseline and week 6 (or last observation after baseline) The Clinical Global Impression of Change (CGI-C) is an assessment performed by the clinician, evaluating the change in the patient's symptoms over time. The clinician categorizes the change as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. The data presented here represents the percentage of patients whose condition showed at least minimal improvement in the CGI-C rating as related to late shift sleepiness (defined as the period 0400-0800, including the commute home).
- Secondary Outcome Measures
Name Time Method Change From Baseline to Endpoint in Global Assessment of Function (GAF) Score Baseline and week 6 (or last observation after baseline) The Global Assessment of Functioning (GAF) is a numeric scale (0 through 100) used by the clinician to rate the social, occupational, and psychological functioning of the patient. A higher score indicates superior functioning and fewer symptoms. The data presented here represents the mean change from baseline to endpoint in the GAF scores of each group.
Change From Baseline to Week 3 in Global Assessment of Functioning Baseline and Week 3 The Global Assessment of Functioning (GAF) is a numeric scale (0 through 100) used by the clinician to rate the social, occupational, and psychological functioning of the patient. A higher score indicates superior functioning and fewer symptoms. The data presented here represents the mean change from baseline in the GAF scores of each group.
Change From Baseline to Week 6 in Global Assessment of Functioning Baseline and Week 6 The Global Assessment of Functioning (GAF) is a numeric scale (0 through 100) used by the clinician to rate the social, occupational, and psychological functioning of the patient. A higher score indicates superior functioning and fewer symptoms. The data presented here represents the mean change from baseline in the GAF scores of each group.
Change From Baseline to Endpoint in the Mean Karolinska Sleepiness Scale (KSS) Score Baseline and week 6 (or last observation after baseline) The Karolinska sleepiness scale is a 10-point scale, on which the participant has to mark his sleepiness during the previous 10 minutes. The scale ranges from 1, which indicates "extremely alert", to 10, which indicates "extremely sleepy, can't stay awake". The KSS was performed by the participant at the baseline visit, week 3, and week 6 (or early termination visit). The score recorded is the average of 3 assessments within ±15 minutes at 0400, 0600, and 0800. The data presented here represents the mean change from baseline in the KSS scores of each group.
Change From Baseline to Week 3 in the Mean Karolinska Sleepiness Scale (KSS) Score Baseline and week 3 The Karolinska sleepiness scale is a 10-point scale, on which the participant has to mark his sleepiness during the previous 10 minutes. The scale ranges from 1, which indicates "extremely alert", to 10, which indicates "extremely sleepy, can't stay awake". The KSS was performed by the participant at the baseline visit, week 3, and week 6 (or early termination visit). The score recorded is the average of 3 assessments within ±15 minutes at 0400, 0600, and 0800. The data presented here represents the mean change from baseline in the KSS scores of each group.
Change From Baseline to Week 6 in the Mean Karolinska Sleepiness Scale (KSS) Score Baseline and week 6 The Karolinska sleepiness scale is a 10-point scale, on which the participant has to mark his sleepiness during the previous 10 minutes. The scale ranges from 1, which indicates "extremely alert", to 10, which indicates "extremely sleepy, can't stay awake". The KSS was performed by the participant at the baseline visit, week 3, and week 6 (or early termination visit). The score recorded is the average of 3 assessments within ±15 minutes at 0400, 0600, and 0800. The data presented here represents the mean change from baseline in the KSS scores of each group.
Percentage of Patients With at Least Minimal Improvement From Baseline in the Clinical Global Impression of Change (CGI-C) Rating as Related to Late Shift Sleepiness at Week 3 Baseline and week 3 The Clinical Global Impression of Change (CGI-C) is an assessment performed by the clinician, evaluating the change in the patient's symptoms over time. The clinician categorizes the change as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. The data presented here represents the percentage of patients whose condition showed at least minimal improvement in the CGI-C rating as related to late shift sleepiness (defined as the period 0400-0800, including the commute home).
Percentage of Patients With at Least Minimal Improvement From Baseline in the Clinical Global Impression of Change (CGI-C) Rating as Related to Late Shift Sleepiness at Week 6 Baseline and week 6 The Clinical Global Impression of Change (CGI-C) is an assessment performed by the clinician, evaluating the change in the patient's symptoms over time. The clinician categorizes the change as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. The data presented here represents the percentage of patients whose condition showed at least minimal improvement in the CGI-C rating as related to late shift sleepiness (defined as the period 0400-0800, including the commute home).
Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Composite Score Baseline and week 6 (or last observation after baseline) Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating "not at all", to 10, indicating "extremely". Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6.
Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Work Item Score Baseline and week 6 (or last observation after baseline) Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating "not at all", to 10, indicating "extremely". Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6.
Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Social Life Item Score Baseline and week 6 (or last observation (or last observation after baseline)) Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating "not at all", to 10, indicating "extremely". Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6.
Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Family Life Item Score Baseline and week 6 (or last observation after baseline) Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating "not at all", to 10, indicating "extremely". Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6.
Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Score - Days Missed Work or Unable to Carry Out Responsibilities Baseline and week 6 (or last observation after baseline) Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating "not at all", to 10, indicating "extremely". Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6.
Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Score - Number of Days of Reduced Productivity Baseline and week 6 (or last observation after baseline) Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating "not at all", to 10, indicating "extremely". Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6.
Treatment Satisfaction Questionnaire for Medication (TSQM)- Effectiveness Score at Endpoint Endpoint TSQM is a 14 question questionnaire assessing satisfaction with the medication. 4 scales are generated: side effects, effectiveness, convenience, and global satisfaction. Subjects responded to the questionnaire at Week 3, Week 6, and last observation after baseline. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Results from the Effectiveness scale are presented here.
Treatment Satisfaction Questionnaire for Medication (TSQM)- Side Effects Score at Endpoint Endpoint TSQM is a 14 question questionnaire assessing satisfaction with the medication. 4 scales are generated: side effects, effectiveness, convenience, and global satisfaction. Subjects responded to the questionnaire at Week 3, Week 6, and last post-baseline observation. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Results from the Side Effects scale are presented here.
Treatment Satisfaction Questionnaire for Medication (TSQM)- Convenience Score at Endpoint Endpoint TSQM is a 14 question questionnaire assessing satisfaction with the medication. 4 scales are generated: side effects, effectiveness, convenience, and global satisfaction. Subjects responded to the questionnaire at Week 3, Week 6, and last observation after baseline. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Results from the Convenience scale are presented here.
Treatment Satisfaction Questionnaire for Medication (TSQM)- Global Satisfaction Score at Endpoint Endpoint TSQM is a 14 question questionnaire assessing satisfaction with the medication. 4 scales are generated: side effects, effectiveness, convenience, and global satisfaction. Subjects responded to the questionnaire at Week 3, Week 6, and last observation after baseline. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Results from the Global Satisfaction scale are presented here.
Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Total Score Baseline and week 6 (or last observation after baseline) FOSQ-10 consists of 10 questions, on a scale of 1-4(1=extreme difficulty 4=no difficulty), measures impact of sleepiness on activities of daily living. Lower score = more difficulty with activity due to lack of sleep. Total score = MEAN of subscale scores (vigilance, productivity, social outcome, intimacy, activity) multiplied by 5. Worst total score is 5 (maximum difficulty) the best is 20 (no difficulty). This data reports CHANGE in total score from baseline to endpoint, with higher (positive) values representing improvement. Worst possible CHANGE value would be -15 best would be +15.
Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Social Outcome Baseline and week 6 (or last observation after baseline) FOSQ-10 consists of 10 questions rated on a scale of 1-4 (1=extreme difficulty, 4=no difficulty), and is used to measure the impact of daytime sleepiness on activities of daily living and quality of life. A total score and 5 subscale (vigilance, general productivity, social outcome, intimacy, and activity level) scores are calculated from the responses. Worst subscale score is 1 (maximum difficulty) and the best score is 4 (no difficulty). This score represents the CHANGE from Baseline in the Social Outcome subscale. Positive change scores represent improvement (possible range -3 to +3).
Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Activity Level Score Baseline and week 6 (or last observation after baseline) FOSQ-10 consists of 10 questions rated on a scale of 1 to 4 (1=extreme difficulty and 4=no difficulty), and is used to measure the impact of daytime sleepiness on activities of daily living and quality of life. A total score and 5 subscale (vigilance, general productivity, social outcome, intimacy, and activity level) scores are calculated from the responses. Worst subscale score is 1 (maximum difficulty) and the best score is 4 (no difficulty). This score represents the CHANGE from Baseline in the Activity level subscale. Positive change scores represent improvement (possible range -3 to +3).
Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) General Productivity Score Baseline and week 6 (or last observation after baseline) FOSQ-10 consists of 10 questions rated on a scale of 1-4 (1=extreme difficulty, 4=no difficulty), and is used to measure the impact of daytime sleepiness on activities of daily living and quality of life. A total score and 5 subscale (vigilance, general productivity, social outcome, intimacy, and activity level) scores are calculated from the responses. Worst subscale score is 1 (maximum difficulty) and the best score is 4 (no difficulty). This score represents the CHANGE from Baseline in the General Productivity subscale. Positive change scores represent improvement (possible range -3 to +3).
Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Vigilance Score Baseline and week 6 (or last observation after baseline) FOSQ-10 consists of 10 questions rated on a scale of 1-4 (1=extreme difficulty, 4=no difficulty), and is used to measure the impact of daytime sleepiness on activities of daily living and quality of life. A total score and 5 subscale (vigilance, general productivity, social outcome, intimacy, and activity level) scores are calculated from the responses. Worst subscale score is 1 (maximum difficulty) and the best score is 4 (no difficulty). This score represents the CHANGE from Baseline in the Vigilance subscale. Positive change scores represent improvement (possible range -3 to +3).
Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Intimacy Baseline and week 6 (or last observation after baseline) FOSQ-10 consists of 10 questions rated on a scale of 1-4 (1=extreme difficulty, 4=no difficulty), and is used to measure the impact of daytime sleepiness on activities of daily living and quality of life. A total score and 5 subscale (vigilance, general productivity, social outcome, intimacy, and activity level) scores are calculated from the responses. Worst subscale score is 1 (maximum difficulty) and the best score is 4 (no difficulty). This score represents the CHANGE from Baseline in the Intimacy subscale. Positive change scores represent improvement (possible range -3 to +3).
Trial Locations
- Locations (61)
Sleepmed Inc
🇺🇸Macon, Georgia, United States
Fort Wayne Neurological Center
🇺🇸Fort Wayne, Indiana, United States
Neurotrials Research Inc
🇺🇸Atlanta, Georgia, United States
Sleep Disorders Center of Georgia-Peachtree
🇺🇸Atlanta, Georgia, United States
Vince and Associates Clinical Research
🇺🇸Overland Park, Kansas, United States
SleepMed of South Carolina
🇺🇸Columbia, South Carolina, United States
MD Clinical
🇺🇸Hallandale Beach, Florida, United States
Mid-South Neurology Center
🇺🇸Germantown, Tennessee, United States
Sleep Health Center
🇺🇸Brighton, Massachusetts, United States
PAB Clinical Research
🇺🇸Brandon, Florida, United States
Compass Research LLC
🇺🇸Orlando, Florida, United States
The Center for Sleep Medicine
🇺🇸Hattiesburg, Mississippi, United States
Avastra Clinical Trials
🇺🇸Midvale, Utah, United States
Miami Research Associates
🇺🇸South Miami, Florida, United States
Broward Research Group
🇺🇸Pembroke Pines, Florida, United States
Central Arkansas Research
🇺🇸Hot Springs, Arkansas, United States
REM Medical Sleep Center
🇺🇸Phoenix, Arizona, United States
Dormir Clinical Trials, Inc.
🇺🇸San Diego, California, United States
SomnoMedics
🇺🇸Tampa, Florida, United States
Goldpoint Clinical Research
🇺🇸Indianapolis, Indiana, United States
Clinical Research Center of Nevada
🇺🇸Las Vegas, Nevada, United States
Community Research Inc
🇺🇸Cincinnati, Ohio, United States
Tri State Sleep Disorders Center
🇺🇸Cincinnati, Ohio, United States
Duke Insomnia & Sleep Research Program
🇺🇸Durham, North Carolina, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
REM Medical Clinical Research
🇺🇸Tucson, Arizona, United States
Clinical Study Centers LLC
🇺🇸Little Rock, Arkansas, United States
Peninsula Sleep Center
🇺🇸Burlingame, California, United States
Southwestern Research Inc
🇺🇸Santa Ana, California, United States
Pacific Sleep Medicine Services Inc
🇺🇸Los Angeles, California, United States
Stanford University Medical Center
🇺🇸Redwood City, California, United States
Pacific Sleep Medicnie Services Inc
🇺🇸Redlands, California, United States
St Johns Medical Plaza Sleep Disorders Center
🇺🇸Santa Monica, California, United States
Florida Sleep Institute
🇺🇸Spring Hill, Florida, United States
Clinical Research Group of St Petersburg
🇺🇸St Petersburg, Florida, United States
Sleep Disorders Center of Georgia-Gainesville
🇺🇸Gainesville, Georgia, United States
Chicago Research Center
🇺🇸Chicago, Illinois, United States
Suburban Lung Associates
🇺🇸Elk Grove Village, Illinois, United States
The Center for Sleep and Wake Disorders d/b/a Midwest Neuro
🇺🇸Danville, Indiana, United States
University of Iowa Hospitals
🇺🇸Iowa City, Iowa, United States
Rehabilitation Associates of Indiana
🇺🇸Indianapolis, Indiana, United States
Kentucky Research Group
🇺🇸Louisville, Kentucky, United States
Community Research
🇺🇸Crestview, Kentucky, United States
Helene A. Emsellem, MD
🇺🇸Chevy Chase, Maryland, United States
Washington University Sleep Medicine Center
🇺🇸St Louis, Missouri, United States
Clayton Sleep Institute LLC
🇺🇸St Louis, Missouri, United States
Somnos Laboratories, Inc d/b/a Somnos Clinical Research
🇺🇸Lincoln, Nebraska, United States
CliniLabs Inc
🇺🇸New York, New York, United States
Wake Research Associates
🇺🇸Raleigh, North Carolina, United States
North Coast Clinical Trials Inc
🇺🇸Beachwood, Ohio, United States
North Star Medical Research LLC
🇺🇸Middleburg Heights, Ohio, United States
Mercy St Anne Sleep Disorder Center
🇺🇸Toledo, Ohio, United States
CRI Worldwide
🇺🇸Philadelphia, Pennsylvania, United States
Consolidated Clinical Trials
🇺🇸Jefferson Hills, Pennsylvania, United States
Southeastern PA Medical Institute
🇺🇸Broomall, Pennsylvania, United States
FutureSearch Trials of Neurology
🇺🇸Austin, Texas, United States
Sleep Lab of Northeastern PA
🇺🇸Summit Hill, Pennsylvania, United States
Sleep Therapy and Research Center
🇺🇸San Antonio, Texas, United States
Kingwood Research Institute
🇺🇸Kingwood, Texas, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
St Mary's of Michigan
🇺🇸Saginaw, Michigan, United States