Clinical trial NCT01080807: Efficacy and Tolerability of Armodafinil in Adults With Excessive Sleepiness Associated With Shift Work Disorder
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Excessive Sleepiness
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2010-03-04
Enrollment: 385
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to determine whether armodafinil treatment is more effective than placebo treatment in patients with excessive sleepiness associated with shift work disorder (SWD) by measuring improved clinical condition late in the shift, including the commute home.


Eligibility 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.

Primary outcomes:
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
timeFrame: Baseline and week 6 (or last observation after baseline)
Secondary outcomes:
measure: Change From Baseline to Endpoint in Global Assessment of Function (GAF) Score
timeFrame: Baseline and week 6 (or last observation after baseline)
measure: Change From Baseline to Week 3 in Global Assessment of Functioning
timeFrame: Baseline and Week 3
measure: Change From Baseline to Week 6 in Global Assessment of Functioning
timeFrame: Baseline and Week 6
measure: Change From Baseline to Endpoint in the Mean Karolinska Sleepiness Scale (KSS) Score
timeFrame: Baseline and week 6 (or last observation after baseline)
measure: Change From Baseline to Week 3 in the Mean Karolinska Sleepiness Scale (KSS) Score
timeFrame: Baseline and week 3
measure: Change From Baseline to Week 6 in the Mean Karolinska Sleepiness Scale (KSS) Score
timeFrame: Baseline and week 6
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 Week 3
timeFrame: Baseline and week 3
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 Week 6
timeFrame: Baseline and week 6
measure: Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Composite Score
timeFrame: Baseline and week 6 (or last observation after baseline)
measure: Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Work Item Score
timeFrame: Baseline and week 6 (or last observation after baseline)
measure: Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Social Life Item Score
timeFrame: Baseline and week 6 (or last observation (or last observation after baseline))
measure: Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Family Life Item Score
timeFrame: Baseline and week 6 (or last observation after baseline)
measure: Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Score - Days Missed Work or Unable to Carry Out Responsibilities
timeFrame: Baseline and week 6 (or last observation after baseline)
measure: Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Score - Number of Days of Reduced Productivity
timeFrame: Baseline and week 6 (or last observation after baseline)
measure: Treatment Satisfaction Questionnaire for Medication (TSQM)- Effectiveness Score at Endpoint
timeFrame: Endpoint
measure: Treatment Satisfaction Questionnaire for Medication (TSQM)- Side Effects Score at Endpoint
timeFrame: Endpoint
measure: Treatment Satisfaction Questionnaire for Medication (TSQM)- Convenience Score at Endpoint
timeFrame: Endpoint
measure: Treatment Satisfaction Questionnaire for Medication (TSQM)- Global Satisfaction Score at Endpoint
timeFrame: Endpoint
measure: Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Total Score
timeFrame: Baseline and week 6 (or last observation after baseline)
measure: Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Activity Level Score
timeFrame: Baseline and week 6 (or last observation after baseline)
measure: Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) General Productivity Score
timeFrame: Baseline and week 6 (or last observation after baseline)
measure: Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Vigilance Score
timeFrame: Baseline and week 6 (or last observation after baseline)
measure: Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Social Outcome
timeFrame: Baseline and week 6 (or last observation after baseline)
measure: Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Intimacy
timeFrame: Baseline and week 6 (or last observation after baseline)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: REM Medical Sleep Center
state: Arizona
city: Tucson
country: United States
facility: REM Medical Clinical Research
state: Arizona
city: Hot Springs
country: United States
facility: Central Arkansas Research
state: Arkansas
city: Little Rock
country: United States
facility: Clinical Study Centers LLC
state: Arkansas
city: Burlingame
country: United States
facility: Peninsula Sleep Center
state: California
city: Fountain Valley
country: United States
facility: Avastra Clinical Trials
state: California
city: Los Angeles
country: United States
facility: Pacific Sleep Medicine Services Inc
state: California
city: Pasadena
country: United States
facility: Southwestern Research Inc
state: California
city: Redlands
country: United States
facility: Pacific Sleep Medicnie Services Inc
state: California
city: Redwood City
country: United States
facility: Stanford University Medical Center
state: California
city: San Diego
country: United States
facility: Dormir Clinical Trials, Inc.
state: California
city: Santa Ana
country: United States
facility: Southwestern Research Inc
state: California
city: Santa Monica
country: United States
facility: St Johns Medical Plaza Sleep Disorders Center
state: California
city: Brandon
country: United States
facility: PAB Clinical Research
state: Florida
city: Hallandale Beach
country: United States
facility: MD Clinical
state: Florida
city: Orlando
country: United States
facility: Compass Research LLC
state: Florida
city: Pembroke Pines
country: United States
facility: Broward Research Group
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Spring Hill
country: United States
facility: Florida Sleep Institute
state: Florida
city: St Petersburg
country: United States
facility: Clinical Research Group of St Petersburg
state: Florida
city: Tampa
country: United States
facility: SomnoMedics
state: Florida
city: Atlanta
country: United States
facility: Neurotrials Research Inc
state: Georgia
city: Atlanta
country: United States
facility: Sleep Disorders Center of Georgia-Peachtree
state: Georgia
city: Gainesville
country: United States
facility: Sleep Disorders Center of Georgia-Gainesville
state: Georgia
city: Macon
country: United States
facility: Sleepmed Inc
state: Georgia
city: Chicago
country: United States
facility: Chicago Research Center
state: Illinois
city: Elk Grove Village
country: United States
facility: Suburban Lung Associates
state: Illinois
city: Danville
country: United States
facility: The Center for Sleep and Wake Disorders d/b/a Midwest Neuro
state: Indiana
city: Fort Wayne
country: United States
facility: Fort Wayne Neurological Center
state: Indiana
city: Indianapolis
country: United States
facility: Rehabilitation Associates of Indiana
state: Indiana
city: Indianapolis
country: United States
facility: Goldpoint Clinical Research
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals
state: Iowa
city: Overland Park
country: United States
facility: Vince and Associates Clinical Research
state: Kansas
city: Crestview
country: United States
facility: Community Research
state: Kentucky
city: Louisville
country: United States
facility: Kentucky Research Group
state: Kentucky
city: Chevy Chase
country: United States
facility: Helene A. Emsellem, MD
state: Maryland
city: Brighton
country: United States
facility: Sleep Health Center
state: Massachusetts
city: Saginaw
country: United States
facility: St Mary's of Michigan
state: Michigan
city: Hattiesburg
country: United States
facility: The Center for Sleep Medicine
state: Mississippi
city: St Louis
country: United States
facility: Washington University Sleep Medicine Center
state: Missouri
city: St Louis
country: United States
facility: Clayton Sleep Institute LLC
state: Missouri
city: Lincoln
country: United States
facility: Somnos Laboratories, Inc d/b/a Somnos Clinical Research
state: Nebraska
city: Las Vegas
country: United States
facility: Clinical Research Center of Nevada
state: Nevada
city: New York
country: United States
facility: CliniLabs Inc
state: New York
city: Durham
country: United States
facility: Duke Insomnia & Sleep Research Program
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Beachwood
country: United States
facility: North Coast Clinical Trials Inc
state: Ohio
city: Cincinnati
country: United States
facility: Community Research Inc
state: Ohio
city: Cincinnati
country: United States
facility: Tri State Sleep Disorders Center
state: Ohio
city: Middleburg Heights
country: United States
facility: North Star Medical Research LLC
state: Ohio
city: Toledo
country: United States
facility: Mercy St Anne Sleep Disorder Center
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Broomall
country: United States
facility: Southeastern PA Medical Institute
state: Pennsylvania
city: Jefferson Hills
country: United States
facility: Consolidated Clinical Trials
state: Pennsylvania
city: Philadelphia
country: United States
facility: CRI Worldwide
state: Pennsylvania
city: Summit Hill
country: United States
facility: Sleep Lab of Northeastern PA
state: Pennsylvania
city: Columbia
country: United States
facility: SleepMed of South Carolina
state: South Carolina
city: Germantown
country: United States
facility: Mid-South Neurology Center
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials of Neurology
state: Texas
city: Kingwood
country: United States
facility: Kingwood Research Institute
state: Texas
city: San Antonio
country: United States
facility: Sleep Therapy and Research Center
state: Texas
city: Midvale
country: United States
facility: Avastra Clinical Trials
state: Utah
Study officials:
affiliation: Cephalon
name: Sponsor's Medical Expert
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.