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

Information source: Teva Pharmaceutical Industries
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Excessive Sleepiness

Intervention: Armodafinil (Drug); Matching Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Cephalon

Official(s) and/or principal investigator(s):
Sponsor's Medical Expert, Study Director, Affiliation: Cephalon

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

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

Secondary outcome:

Change From Baseline to Endpoint in Global Assessment of Function (GAF) Score

Change From Baseline to Week 3 in Global Assessment of Functioning

Change From Baseline to Week 6 in Global Assessment of Functioning

Change From Baseline to Endpoint in the Mean Karolinska Sleepiness Scale (KSS) Score

Change From Baseline to Week 3 in the Mean Karolinska Sleepiness Scale (KSS) Score

Change From Baseline to Week 6 in the Mean Karolinska Sleepiness Scale (KSS) Score

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

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

Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Composite Score

Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Work Item Score

Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Social Life Item Score

Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Family Life Item Score

Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Score - Days Missed Work or Unable to Carry Out Responsibilities

Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Score - Number of Days of Reduced Productivity

Treatment Satisfaction Questionnaire for Medication (TSQM)- Effectiveness Score at Endpoint

Treatment Satisfaction Questionnaire for Medication (TSQM)- Side Effects Score at Endpoint

Treatment Satisfaction Questionnaire for Medication (TSQM)- Convenience Score at Endpoint

Treatment Satisfaction Questionnaire for Medication (TSQM)- Global Satisfaction Score at Endpoint

Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Total Score

Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Activity Level Score

Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) General Productivity Score

Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Vigilance Score

Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Social Outcome

Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Intimacy

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

REM Medical Sleep Center, Phoenix, Arizona 85037, United States

REM Medical Clinical Research, Tucson, Arizona 85712, United States

Central Arkansas Research, Hot Springs, Arkansas 71913, United States

Clinical Study Centers LLC, Little Rock, Arkansas 72205, United States

Peninsula Sleep Center, Burlingame, California 94010, United States

Avastra Clinical Trials, Fountain Valley, California 92708, United States

Pacific Sleep Medicine Services Inc, Los Angeles, California 90048, United States

Southwestern Research Inc, Pasadena, California 91106, United States

Pacific Sleep Medicnie Services Inc, Redlands, California 92373, United States

Stanford University Medical Center, Redwood City, California 94063, United States

Dormir Clinical Trials, Inc., San Diego, California 92121, United States

Southwestern Research Inc, Santa Ana, California 92705, United States

St Johns Medical Plaza Sleep Disorders Center, Santa Monica, California 90404, United States

PAB Clinical Research, Brandon, Florida 33511, United States

MD Clinical, Hallandale Beach, Florida 33009, United States

Compass Research LLC, Orlando, Florida 32806, United States

Broward Research Group, Pembroke Pines, Florida 33026, United States

Miami Research Associates, South Miami, Florida 33143, United States

Florida Sleep Institute, Spring Hill, Florida 34609, United States

Clinical Research Group of St Petersburg, St Petersburg, Florida 33707, United States

SomnoMedics, Tampa, Florida 33607, United States

Neurotrials Research Inc, Atlanta, Georgia 30342, United States

Sleep Disorders Center of Georgia-Peachtree, Atlanta, Georgia 30342, United States

Sleep Disorders Center of Georgia-Gainesville, Gainesville, Georgia 30501, United States

Sleepmed Inc, Macon, Georgia 31201, United States

Chicago Research Center, Chicago, Illinois 60634, United States

Suburban Lung Associates, Elk Grove Village, Illinois 60007, United States

The Center for Sleep and Wake Disorders d/b/a Midwest Neuro, Danville, Indiana 46122, United States

Fort Wayne Neurological Center, Fort Wayne, Indiana 46804, United States

Goldpoint Clinical Research, Indianapolis, Indiana 46260, United States

Rehabilitation Associates of Indiana, Indianapolis, Indiana 46250, United States

University of Iowa Hospitals, Iowa City, Iowa 52242, United States

Vince and Associates Clinical Research, Overland Park, Kansas 66212, United States

Community Research, Crestview, Kentucky 41017, United States

Kentucky Research Group, Louisville, Kentucky 40217, United States

Helene A. Emsellem, MD, Chevy Chase, Maryland 20815, United States

Sleep Health Center, Brighton, Massachusetts 02135, United States

St Mary's of Michigan, Saginaw, Michigan 48604, United States

The Center for Sleep Medicine, Hattiesburg, Mississippi 39402, United States

Clayton Sleep Institute LLC, St Louis, Missouri 63143, United States

Washington University Sleep Medicine Center, St Louis, Missouri 63108, United States

Somnos Laboratories, Inc d/b/a Somnos Clinical Research, Lincoln, Nebraska 68510, United States

Clinical Research Center of Nevada, Las Vegas, Nevada 89104, United States

CliniLabs Inc, New York, New York 10019, United States

Duke Insomnia & Sleep Research Program, Durham, North Carolina 27710, United States

Wake Research Associates, Raleigh, North Carolina 27612, United States

Wake Forest University Health Sciences, Winston-Salem, North Carolina 27157, United States

North Coast Clinical Trials Inc, Beachwood, Ohio 44122, United States

Community Research Inc, Cincinnati, Ohio 45227, United States

Tri State Sleep Disorders Center, Cincinnati, Ohio 45246, United States

North Star Medical Research LLC, Middleburg Heights, Ohio 44130, United States

Mercy St Anne Sleep Disorder Center, Toledo, Ohio 43623, United States

Lynn Health Science Institute, Oklahoma City, Oklahoma 73112, United States

Southeastern PA Medical Institute, Broomall, Pennsylvania 19008, United States

Consolidated Clinical Trials, Jefferson Hills, Pennsylvania 15025, United States

CRI Worldwide, Philadelphia, Pennsylvania 19139, United States

Sleep Lab of Northeastern PA, Summit Hill, Pennsylvania 18411, United States

SleepMed of South Carolina, Columbia, South Carolina 29201, United States

Mid-South Neurology Center, Germantown, Tennessee 38139, United States

FutureSearch Trials of Neurology, Austin, Texas 78756, United States

Kingwood Research Institute, Kingwood, Texas 77339, United States

Sleep Therapy and Research Center, San Antonio, Texas 78250, United States

Avastra Clinical Trials, Midvale, Utah 84047, United States

Additional Information

Starting date: March 2010
Last updated: May 17, 2012

Page last updated: August 23, 2015

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