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

NCT01080807 | Completed Phase 4 Results

• 1 other identifier: C10953/4030
• Study Type: interventional
• Target: 385
• Locations: 1 country
• Sites: 63

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.

Conditions

Excessive Sleepiness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (24)

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

  Baseline and week 6 (or last observation after baseline)

• Change From Baseline to Week 3 in Global Assessment of Functioning

  Baseline and Week 3

• Change From Baseline to Week 6 in Global Assessment of Functioning

  Baseline and Week 6

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

  Baseline and week 6 (or last observation after baseline)

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

  Baseline and week 3

Study Arms (2)

150 mg/day armodafinil

EXPERIMENTAL

Drug: Armodafinil

Matching placebo

PLACEBO COMPARATOR

Drug: Matching Placebo

Interventions

Armodafinil DRUG

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.

Also known as: R-modafinil, CEP-10953

150 mg/day armodafinil

Matching Placebo DRUG

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Cephalon: lead

Study Sites (63)

REM Medical Sleep Center

Phoenix, Arizona, 85037, United States

Location

REM Medical Clinical Research

Tucson, Arizona, 85712, United States

Location

Central Arkansas Research

Hot Springs, Arkansas, 71913, United States

Location

Clinical Study Centers LLC

Little Rock, Arkansas, 72205, United States

Location

Peninsula Sleep Center

Burlingame, California, 94010, United States

Location

Avastra Clinical Trials

Fountain Valley, California, 92708, United States

Location

Pacific Sleep Medicine Services Inc

Los Angeles, California, 90048, United States

Location

Southwestern Research Inc

Pasadena, California, 91106, United States

Location

Pacific Sleep Medicnie Services Inc

Redlands, California, 92373, United States

Location

Stanford University Medical Center

Redwood City, California, 94063, United States

Location

Dormir Clinical Trials, Inc.

San Diego, California, 92121, United States

Location

Southwestern Research Inc

Santa Ana, California, 92705, United States

Location

St Johns Medical Plaza Sleep Disorders Center

Santa Monica, California, 90404, United States

Location

PAB Clinical Research

Brandon, Florida, 33511, United States

Location

MD Clinical

Hallandale, Florida, 33009, United States

Location

Compass Research LLC

Orlando, Florida, 32806, United States

Location

Broward Research Group

Pembroke Pines, Florida, 33026, United States

Location

Miami Research Associates

South Miami, Florida, 33143, United States

Location

Florida Sleep Institute

Spring Hill, Florida, 34609, United States

Location

Clinical Research Group of St Petersburg

St. Petersburg, Florida, 33707, United States

Location

SomnoMedics

Tampa, Florida, 33607, United States

Location

Neurotrials Research Inc

Atlanta, Georgia, 30342, United States

Location

Sleep Disorders Center of Georgia-Peachtree

Atlanta, Georgia, 30342, United States

Location

Sleep Disorders Center of Georgia-Gainesville

Gainesville, Georgia, 30501, United States

Location

Sleepmed Inc

Macon, Georgia, 31201, United States

Location

Chicago Research Center

Chicago, Illinois, 60634, United States

Location

Suburban Lung Associates

Elk Grove Village, Illinois, 60007, United States

Location

The Center for Sleep and Wake Disorders d/b/a Midwest Neuro

Danville, Indiana, 46122, United States

Location

Fort Wayne Neurological Center

Fort Wayne, Indiana, 46804, United States

Location

Rehabilitation Associates of Indiana

Indianapolis, Indiana, 46250, United States

Location

Goldpoint Clinical Research

Indianapolis, Indiana, 46260, United States

Location

University of Iowa Hospitals

Iowa City, Iowa, 52242, United States

Location

Vince and Associates Clinical Research

Overland Park, Kansas, 66212, United States

Location

Community Research

Crestview, Kentucky, 41017, United States

Location

Kentucky Research Group

Louisville, Kentucky, 40217, United States

Location

Helene A. Emsellem, MD

Chevy Chase, Maryland, 20815, United States

Location

Sleep Health Center

Brighton, Massachusetts, 02135, United States

Location

St Mary's of Michigan

Saginaw, Michigan, 48604, United States

Location

The Center for Sleep Medicine

Hattiesburg, Mississippi, 39402, United States

Location

Washington University Sleep Medicine Center

St Louis, Missouri, 63108, United States

Location

Clayton Sleep Institute LLC

St Louis, Missouri, 63143, United States

Location

Somnos Laboratories, Inc d/b/a Somnos Clinical Research

Lincoln, Nebraska, 68510, United States

Location

Clinical Research Center of Nevada

Las Vegas, Nevada, 89104, United States

Location

CliniLabs Inc

New York, New York, 10019, United States

Location

Duke Insomnia & Sleep Research Program

Durham, North Carolina, 27710, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

North Coast Clinical Trials Inc

Beachwood, Ohio, 44122, United States

Location

Community Research Inc

Cincinnati, Ohio, 45227, United States

Location

Tri State Sleep Disorders Center

Cincinnati, Ohio, 45246, United States

Location

North Star Medical Research LLC

Middleburg Heights, Ohio, 44130, United States

Location

Mercy St Anne Sleep Disorder Center

Toledo, Ohio, 43623, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Southeastern PA Medical Institute

Broomall, Pennsylvania, 19008, United States

Location

Consolidated Clinical Trials

Jefferson Hills, Pennsylvania, 15025, United States

Location

CRI Worldwide

Philadelphia, Pennsylvania, 19139, United States

Location

Sleep Lab of Northeastern PA

Summit Hill, Pennsylvania, 18411, United States

Location

SleepMed of South Carolina

Columbia, South Carolina, 29201, United States

Location

Mid-South Neurology Center

Germantown, Tennessee, 38139, United States

Location

FutureSearch Trials of Neurology

Austin, Texas, 78756, United States

Location

Kingwood Research Institute

Kingwood, Texas, 77339, United States

Location

Sleep Therapy and Research Center

San Antonio, Texas, 78250, United States

Location

Avastra Clinical Trials

Midvale, Utah, 84047, United States

Location

Related Publications (2)

• 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.

  PMID: 23251870 DERIVED

• 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.

  PMID: 22104981 DERIVED

MeSH Terms

Conditions

Disorders of Excessive Somnolence

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Vice President, Medical Affairs
• Organization: Cephalon, Inc.

610-727-6353

Study Officials

• Sponsor's Medical Expert

  Cephalon

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2010
• First Posted: March 4, 2010
• Study Start: March 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: June 20, 2012
• Results First Posted: June 20, 2012

Record last verified: 2012-05

Locations

US (63)