Efficacy and Tolerability of Armodafinil in Adults With Excessive Sleepiness Associated With Shift Work Disorder
NCT ID: NCT01080807
Last Updated: 2012-06-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
385 participants
INTERVENTIONAL
2010-03-31
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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150 mg/day armodafinil
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.
Matching placebo
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
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Cephalon
INDUSTRY
Responsible Party
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Principal Investigators
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Sponsor's Medical Expert
Role: STUDY_DIRECTOR
Cephalon
Locations
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REM Medical Sleep Center
Phoenix, Arizona, United States
REM Medical Clinical Research
Tucson, Arizona, United States
Central Arkansas Research
Hot Springs, Arkansas, United States
Clinical Study Centers LLC
Little Rock, Arkansas, United States
Peninsula Sleep Center
Burlingame, California, United States
Avastra Clinical Trials
Fountain Valley, California, United States
Pacific Sleep Medicine Services Inc
Los Angeles, California, United States
Southwestern Research Inc
Pasadena, California, United States
Pacific Sleep Medicnie Services Inc
Redlands, California, United States
Stanford University Medical Center
Redwood City, California, United States
Dormir Clinical Trials, Inc.
San Diego, California, United States
Southwestern Research Inc
Santa Ana, California, United States
St Johns Medical Plaza Sleep Disorders Center
Santa Monica, California, United States
PAB Clinical Research
Brandon, Florida, United States
MD Clinical
Hallandale, Florida, United States
Compass Research LLC
Orlando, Florida, United States
Broward Research Group
Pembroke Pines, Florida, United States
Miami Research Associates
South Miami, Florida, United States
Florida Sleep Institute
Spring Hill, Florida, United States
Clinical Research Group of St Petersburg
St. Petersburg, Florida, United States
SomnoMedics
Tampa, Florida, United States
Neurotrials Research Inc
Atlanta, Georgia, United States
Sleep Disorders Center of Georgia-Peachtree
Atlanta, Georgia, United States
Sleep Disorders Center of Georgia-Gainesville
Gainesville, Georgia, United States
Sleepmed Inc
Macon, 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
Fort Wayne Neurological Center
Fort Wayne, Indiana, United States
Rehabilitation Associates of Indiana
Indianapolis, Indiana, United States
Goldpoint Clinical Research
Indianapolis, Indiana, United States
University of Iowa Hospitals
Iowa City, Iowa, United States
Vince and Associates Clinical Research
Overland Park, Kansas, United States
Community Research
Crestview, Kentucky, United States
Kentucky Research Group
Louisville, Kentucky, United States
Helene A. Emsellem, MD
Chevy Chase, Maryland, United States
Sleep Health Center
Brighton, Massachusetts, United States
St Mary's of Michigan
Saginaw, Michigan, United States
The Center for Sleep Medicine
Hattiesburg, Mississippi, 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
Clinical Research Center of Nevada
Las Vegas, Nevada, United States
CliniLabs Inc
New York, New York, United States
Duke Insomnia & Sleep Research Program
Durham, North Carolina, United States
Wake Research Associates
Raleigh, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
North Coast Clinical Trials Inc
Beachwood, Ohio, United States
Community Research Inc
Cincinnati, Ohio, United States
Tri State Sleep Disorders Center
Cincinnati, Ohio, United States
North Star Medical Research LLC
Middleburg Heights, Ohio, United States
Mercy St Anne Sleep Disorder Center
Toledo, Ohio, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Southeastern PA Medical Institute
Broomall, Pennsylvania, United States
Consolidated Clinical Trials
Jefferson Hills, Pennsylvania, United States
CRI Worldwide
Philadelphia, Pennsylvania, United States
Sleep Lab of Northeastern PA
Summit Hill, Pennsylvania, United States
SleepMed of South Carolina
Columbia, South Carolina, United States
Mid-South Neurology Center
Germantown, Tennessee, United States
FutureSearch Trials of Neurology
Austin, Texas, United States
Kingwood Research Institute
Kingwood, Texas, United States
Sleep Therapy and Research Center
San Antonio, Texas, United States
Avastra Clinical Trials
Midvale, Utah, United States
Countries
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References
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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.
Other Identifiers
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C10953/4030
Identifier Type: -
Identifier Source: org_study_id
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