Excessive SleepinessPhase 4NCT01080807
Efficacy and Tolerability of Armodafinil in Adults With Excessive Sleepiness Associated With Shift Work Disorder
A Phase 4 study testing Armodafinil in people with Excessive Sleepiness, run by Cephalon at 63 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Excessive Sleepiness
- What is being tested?
- Armodafinil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 385 participants
- Where
- 63 sitesUnited States
- Study dates
- Mar 2010to Oct 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
63 sites in 1 country.
63 sites in 1 country
United States63 sites
Neurotrials Research Inc
Atlanta, Georgia, 30342
Sleep Disorders Center of Georgia-Peachtree
Atlanta, Georgia, 30342
FutureSearch Trials of Neurology
Austin, Texas, 78756
North Coast Clinical Trials Inc
Beachwood, Ohio, 44122
PAB Clinical Research
Brandon, Florida, 33511
Sleep Health Center
Brighton, Massachusetts, 02135
Southeastern PA Medical Institute
Broomall, Pennsylvania, 19008
Peninsula Sleep Center
Burlingame, California, 94010
Helene A. Emsellem, MD
Chevy Chase, Maryland, 20815
Chicago Research Center
Chicago, Illinois, 60634
Community Research Inc
Cincinnati, Ohio, 45227
Tri State Sleep Disorders Center
Cincinnati, Ohio, 45246
SleepMed of South Carolina
Columbia, South Carolina, 29201
Community Research
Crestview, Kentucky, 41017
The Center for Sleep and Wake Disorders d/b/a Midwest Neuro
Danville, Indiana, 46122
Duke Insomnia & Sleep Research Program
Durham, North Carolina, 27710
Suburban Lung Associates
Elk Grove Village, Illinois, 60007
Fort Wayne Neurological Center
Fort Wayne, Indiana, 46804
Avastra Clinical Trials
Fountain Valley, California, 92708
Sleep Disorders Center of Georgia-Gainesville
Gainesville, Georgia, 30501
Mid-South Neurology Center
Germantown, Tennessee, 38139
MD Clinical
Hallandale, Florida, 33009
The Center for Sleep Medicine
Hattiesburg, Mississippi, 39402
Central Arkansas Research
Hot Springs, Arkansas, 71913
Rehabilitation Associates of Indiana
Indianapolis, Indiana, 46250
Goldpoint Clinical Research
Indianapolis, Indiana, 46260
University of Iowa Hospitals
Iowa City, Iowa, 52242
Consolidated Clinical Trials
Jefferson Hills, Pennsylvania, 15025
Kingwood Research Institute
Kingwood, Texas, 77339
Clinical Research Center of Nevada
Las Vegas, Nevada, 89104
Somnos Laboratories, Inc d/b/a Somnos Clinical Research
Lincoln, Nebraska, 68510
Clinical Study Centers LLC
Little Rock, Arkansas, 72205
Pacific Sleep Medicine Services Inc
Los Angeles, California, 90048
Kentucky Research Group
Louisville, Kentucky, 40217
Sleepmed Inc
Macon, Georgia, 31201
North Star Medical Research LLC
Middleburg Heights, Ohio, 44130
Avastra Clinical Trials
Midvale, Utah, 84047
CliniLabs Inc
New York, New York, 10019
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
Compass Research LLC
Orlando, Florida, 32806
Vince and Associates Clinical Research
Overland Park, Kansas, 66212
Southwestern Research Inc
Pasadena, California, 91106
Broward Research Group
Pembroke Pines, Florida, 33026
CRI Worldwide
Philadelphia, Pennsylvania, 19139
REM Medical Sleep Center
Phoenix, Arizona, 85037
Wake Research Associates
Raleigh, North Carolina, 27612
Pacific Sleep Medicnie Services Inc
Redlands, California, 92373
Stanford University Medical Center
Redwood City, California, 94063
St Mary's of Michigan
Saginaw, Michigan, 48604
Sleep Therapy and Research Center
San Antonio, Texas, 78250
Dormir Clinical Trials, Inc.
San Diego, California, 92121
Southwestern Research Inc
Santa Ana, California, 92705
St Johns Medical Plaza Sleep Disorders Center
Santa Monica, California, 90404
Miami Research Associates
South Miami, Florida, 33143
Florida Sleep Institute
Spring Hill, Florida, 34609
Washington University Sleep Medicine Center
St Louis, Missouri, 63108
Clayton Sleep Institute LLC
St Louis, Missouri, 63143
Clinical Research Group of St Petersburg
St. Petersburg, Florida, 33707
Sleep Lab of Northeastern PA
Summit Hill, Pennsylvania, 18411
SomnoMedics
Tampa, Florida, 33607
Mercy St Anne Sleep Disorder Center
Toledo, Ohio, 43623
REM Medical Clinical Research
Tucson, Arizona, 85712
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: 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.
- Conditions
- Excessive Sleepiness
- Being tested
- Armodafinil, Matching Placebo
- Medical subject headings
- Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArmodafinilDrug
Also called R-modafinil, CEP-10953
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.
Matching PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 150 mg/day armodafinil | Experimental | Not described Receives: Drug: Armodafinil |
| Matching placebo | Placebo comparator | Not described Receives: Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and week 6 (or last observation after baseline)
Secondary outcomes (24)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline and week 6 (or last observation after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Excessive SleepinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cephalon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sponsor's Medical Expert, Study director, Cephalon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01080807
- Sponsor's protocol ID
- C10953/4030
- Status last verified
- May 2012
- First submitted
- 3 Mar 2010
- Last updated
- 20 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
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.
PubMed 23251870Erman 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.
PubMed 22104981
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01080807
- Acronym / sponsor ID
- C10953/4030
- Conditions
- Excessive Sleepiness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- CephalonIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 4 Mar 2010 (estimated)
- Results
- Posted 20 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 150 mg/day armodafinil | Experimental | Drug: Armodafinil |
| Matching placebo | Placebo comparator | Drug: Matching Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArmodafinilAlso: R-modafinil, CEP-10953At 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. | Drug | 150 mg/day armodafinil |
| Matching PlaceboAt 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. | Drug | Matching placebo |
Primary outcome
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
Time frame: 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).
24 secondary outcomes
Change From Baseline to Endpoint in Global Assessment of Function (GAF) Score
Time frame: Baseline and week 6 (or last observation after baseline)
Change From Baseline to Week 3 in Global Assessment of Functioning
Time frame: Baseline and Week 3
Change From Baseline to Week 6 in Global Assessment of Functioning
Time frame: Baseline and Week 6
Change From Baseline to Endpoint in the Mean Karolinska Sleepiness Scale (KSS) Score
Time frame: Baseline and week 6 (or last observation after baseline)
Change From Baseline to Week 3 in the Mean Karolinska Sleepiness Scale (KSS) Score
Time frame: Baseline and week 3
Change From Baseline to Week 6 in the Mean Karolinska Sleepiness Scale (KSS) Score
Time frame: 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
Time frame: 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
Time frame: Baseline and week 6
Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Composite Score
Time frame: Baseline and week 6 (or last observation after baseline)
Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Work Item Score
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline and week 6 (or last observation after baseline)
Treatment Satisfaction Questionnaire for Medication (TSQM)- Effectiveness Score at Endpoint
Time frame: Endpoint
Treatment Satisfaction Questionnaire for Medication (TSQM)- Side Effects Score at Endpoint
Time frame: Endpoint
Treatment Satisfaction Questionnaire for Medication (TSQM)- Convenience Score at Endpoint
Time frame: Endpoint
Treatment Satisfaction Questionnaire for Medication (TSQM)- Global Satisfaction Score at Endpoint
Time frame: Endpoint
Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Total Score
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline and week 6 (or last observation after baseline)
Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Intimacy
Time frame: Baseline and week 6 (or last observation after baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23251870Erman 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.
- Derived from this study: PubMed 22104981Erman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sponsor's Medical Expert study director
Cephalon
63 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Armodafinil in people with Excessive Sleepiness, run by Cephalon at 63 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 63 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline and week 6 (or last observation after baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01080807, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2012.