Efficacy and Tolerability of Armodafinil in Adults With Excessive Sleepiness Associated With Shift Work Disorder

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Tolerability of Armodafinil Treatment (150 mg) in Improving Clinical Condition Late in the Shift and in Improving Functional and Patient-Reported Outcomes in Adult Patients With Excessive Sleepiness Associated With Shift Work Disorder

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.

Study Overview

• Status: Completed
• Conditions: Excessive Sleepiness
• Intervention / Treatment: Drug: Armodafinil; Drug: Matching Placebo

• Study Type: Interventional
• Enrollment (Actual): 385
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85037
      • REM Medical Sleep Center
    • Tucson, Arizona, United States, 85712
      • REM Medical Clinical Research
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Central Arkansas Research
    • Little Rock, Arkansas, United States, 72205
      • Clinical Study Centers LLC
  • California
    • Burlingame, California, United States, 94010
      • Peninsula Sleep Center
    • Fountain Valley, California, United States, 92708
      • Avastra Clinical Trials
    • Los Angeles, California, United States, 90048
      • Pacific Sleep Medicine Services Inc
    • Pasadena, California, United States, 91106
      • Southwestern Research Inc
    • Redlands, California, United States, 92373
      • Pacific Sleep Medicnie Services Inc
    • Redwood City, California, United States, 94063
      • Stanford University Medical Center
    • San Diego, California, United States, 92121
      • Dormir Clinical Trials, Inc.
    • Santa Ana, California, United States, 92705
      • Southwestern Research Inc
    • Santa Monica, California, United States, 90404
      • St Johns Medical Plaza Sleep Disorders Center
  • Florida
    • Brandon, Florida, United States, 33511
      • PAB Clinical Research
    • Hallandale Beach, Florida, United States, 33009
      • MD Clinical
    • Orlando, Florida, United States, 32806
      • Compass Research LLC
    • Pembroke Pines, Florida, United States, 33026
      • Broward Research Group
    • South Miami, Florida, United States, 33143
      • Miami Research Associates
    • Spring Hill, Florida, United States, 34609
      • Florida Sleep Institute
    • St Petersburg, Florida, United States, 33707
      • Clinical Research Group of St Petersburg
    • Tampa, Florida, United States, 33607
      • SomnoMedics
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • NeuroTrials Research Inc
    • Atlanta, Georgia, United States, 30342
      • Sleep Disorders Center of Georgia-Peachtree
    • Gainesville, Georgia, United States, 30501
      • Sleep Disorders Center of Georgia-Gainesville
    • Macon, Georgia, United States, 31201
      • Sleepmed Inc
  • Illinois
    • Chicago, Illinois, United States, 60634
      • Chicago Research Center
    • Elk Grove Village, Illinois, United States, 60007
      • Suburban Lung Associates
  • Indiana
    • Danville, Indiana, United States, 46122
      • The Center for Sleep and Wake Disorders d/b/a Midwest Neuro
    • Fort Wayne, Indiana, United States, 46804
      • Fort Wayne Neurological Center
    • Indianapolis, Indiana, United States, 46250
      • Rehabilitation Associates of Indiana
    • Indianapolis, Indiana, United States, 46260
      • Goldpoint Clinical Research
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • Vince and Associates Clinical Research
  • Kentucky
    • Crestview, Kentucky, United States, 41017
      • Community Research
    • Louisville, Kentucky, United States, 40217
      • Kentucky Research Group
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Helene A. Emsellem, MD
  • Massachusetts
    • Brighton, Massachusetts, United States, 02135
      • Sleep Health Center
  • Michigan
    • Saginaw, Michigan, United States, 48604
      • St Mary's of Michigan
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39402
      • The Center for Sleep Medicine
  • Missouri
    • St Louis, Missouri, United States, 63108
      • Washington University Sleep Medicine Center
    • St Louis, Missouri, United States, 63143
      • Clayton Sleep Institute LLC
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Somnos Laboratories, Inc d/b/a Somnos Clinical Research
  • Nevada
    • Las Vegas, Nevada, United States, 89104
      • Clinical Research Center Of Nevada
  • New York
    • New York, New York, United States, 10019
      • CliniLabs Inc
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Insomnia & Sleep Research Program
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • North Coast Clinical Trials Inc
    • Cincinnati, Ohio, United States, 45227
      • Community Research Inc
    • Cincinnati, Ohio, United States, 45246
      • Tri State Sleep Disorders Center
    • Middleburg Heights, Ohio, United States, 44130
      • North Star Medical Research LLC
    • Toledo, Ohio, United States, 43623
      • Mercy St Anne Sleep Disorder Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
  • Pennsylvania
    • Broomall, Pennsylvania, United States, 19008
      • Southeastern PA Medical Institute
    • Jefferson Hills, Pennsylvania, United States, 15025
      • Consolidated Clinical Trials
    • Philadelphia, Pennsylvania, United States, 19139
      • CRI Worldwide
    • Summit Hill, Pennsylvania, United States, 18411
      • Sleep Lab of Northeastern PA
  • South Carolina
    • Columbia, South Carolina, United States, 29201
      • SleepMed of South Carolina
  • Tennessee
    • Germantown, Tennessee, United States, 38139
      • Mid-South Neurology Center
  • Texas
    • Austin, Texas, United States, 78756
      • FutureSearch Trials of Neurology
    • Kingwood, Texas, United States, 77339
      • Kingwood Research Institute
    • San Antonio, Texas, United States, 78250
      • Sleep Therapy and Research Center
  • Utah
    • Midvale, Utah, United States, 84047
      • Avastra Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. The patient currently meets the criteria for Shift Work Disorder (SWD) for duration of at least 1 month.
2. 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.
3. 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.
4. The patient has a Karolinska Sleepiness Scale (KSS) score of 6 or more at screening (visit 1) that is confirmed at baseline (visit 2).
5. The patient works at least 5 night shifts per month, of which at least 3 nights are consecutive, and plans to maintain this schedule.
6. 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.
7. The patient is in good health, as judged by the investigator.
8. The patient is able to complete self-rating scales.
9. 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).
10. The patient is willing and able to comply with study restrictions and to attend regularly scheduled clinic visits as specified in this protocol

Exclusion Criteria:

1. 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).
2. The patient has a medical or psychiatric disorder causing clinically significant functional impairment or contributing to the patient's excessive sleepiness.
3. The patient is currently taking a medication or substance that is causing clinically significant functional impairment or contributing to the patient's excessive sleepiness.
4. The patient has a clinically significant treated or untreated medical condition.
5. 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.
6. The patient has a known hypersensitivity to armodafinil, racemic modafinil, or any component of the study drug tablets.
7. 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.
8. 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.
9. The patient uses any prescription or over-the-counter (OTC) drugs disallowed by the protocol within 30 days of the baseline visit.
10. The patient has been in a prior armodafinil study.
11. The patient has a history of alcohol, narcotic, or any other drug abuse.
12. The patient has a positive urine drug screen (UDS) without medical explanation at the screening visit.
13. The patient has a clinically significant deviation from normal on physical examination.
14. The patient is a pregnant or lactating woman.
15. The patient has used an investigational drug within 1 month of the screening visit.
16. The patient has a disorder that could interfere with the absorption, distribution, metabolism, or excretion of the investigational product.
17. The patient needs to use any of the excluded medications in this protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Matching placebo	Drug: Matching Placebo; At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
EXPERIMENTAL: 150 mg/day armodafinil	Drug: Armodafinil; At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.; Other Names: CEP-10953; R-modafinil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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).	Baseline and week 6 (or last observation after baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to Endpoint in Global Assessment of Function (GAF) Score	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.	Baseline and week 6 (or last observation after baseline)
Change From Baseline to Week 3 in Global Assessment of Functioning	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.	Baseline and Week 3
Change From Baseline to Week 6 in Global Assessment of Functioning	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.	Baseline and Week 6
Change From Baseline to Endpoint in the Mean Karolinska Sleepiness Scale (KSS) Score	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.	Baseline and week 6 (or last observation after baseline)
Change From Baseline to Week 3 in the Mean Karolinska Sleepiness Scale (KSS) Score	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.	Baseline and week 3
Change From Baseline to Week 6 in the Mean Karolinska Sleepiness Scale (KSS) Score	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.	Baseline and week 6
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	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).	Baseline and week 3
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	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).	Baseline and week 6
Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Composite Score	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.	Baseline and week 6 (or last observation after baseline)
Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Work Item Score	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.	Baseline and week 6 (or last observation after baseline)
Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Social Life Item Score	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.	Baseline and week 6 (or last observation (or last observation after baseline))
Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Family Life Item Score	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.	Baseline and week 6 (or last observation after baseline)
Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Score - Days Missed Work or Unable to Carry Out Responsibilities	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.	Baseline and week 6 (or last observation after baseline)
Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Score - Number of Days of Reduced Productivity	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.	Baseline and week 6 (or last observation after baseline)
Treatment Satisfaction Questionnaire for Medication (TSQM)- Effectiveness Score at 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.	Endpoint
Treatment Satisfaction Questionnaire for Medication (TSQM)- Side Effects Score at 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.	Endpoint
Treatment Satisfaction Questionnaire for Medication (TSQM)- Convenience Score at 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.	Endpoint
Treatment Satisfaction Questionnaire for Medication (TSQM)- Global Satisfaction Score at 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.	Endpoint
Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Total Score	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.	Baseline and week 6 (or last observation after baseline)
Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Activity Level Score	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).	Baseline and week 6 (or last observation after baseline)
Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) General Productivity Score	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).	Baseline and week 6 (or last observation after baseline)
Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Vigilance Score	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).	Baseline and week 6 (or last observation after baseline)
Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Social Outcome	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).	Baseline and week 6 (or last observation after baseline)
Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Intimacy	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).	Baseline and week 6 (or last observation after baseline)

Collaborators and Investigators

• Sponsor: Cephalon

Publications and helpful links

General Publications

• Erman MK, Yang R, Seiden DJ. The effect of armodafinil on patient-reported functioning and quality of life in patients with excessive sleepiness associated with shift work disorder: a randomized, double-blind, placebo-controlled trial. Prim Care Companion CNS Disord. 2012;14(4):PCC.12m01345. doi: 10.4088/PCC.12m01345. Epub 2012 Aug 9.
• Erman MK, Seiden DJ, Yang R, Dammerman R. Efficacy and tolerability of armodafinil: effect on clinical condition late in the shift and overall functioning of patients with excessive sleepiness associated with shift work disorder. J Occup Environ Med. 2011 Dec;53(12):1460-5. doi: 10.1097/JOM.0b013e318237a17e.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (ACTUAL): October 1, 2010
• Study Completion (ACTUAL): October 1, 2010

Study Registration Dates

• First Submitted: March 3, 2010
• First Submitted That Met QC Criteria: March 3, 2010
• First Posted (ESTIMATE): March 4, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): June 20, 2012
• Last Update Submitted That Met QC Criteria: May 17, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disorders of Excessive Somnolence; Sleepiness; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Central Nervous System Stimulants; Wakefulness-Promoting Agents; Modafinil
• Other Study ID Numbers: C10953/4030