Study of the Efficacy and Multiple-Dose Plasma Concentration-Time Profiles of Armodafinil and PROVIGIL

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00236080
First received: October 7, 2005
Last updated: July 12, 2013
Last verified: July 2013
  Purpose

The purpose of the study is to compare the overnight efficacy and plasma concentration-time profiles of armodafinil and PROVIGIL, after multiple doses, in patients with excessive sleepiness associated with chronic Shift Work Sleep Disorder (SWSD).


Condition Intervention Phase
Chronic Shift Work Sleep Disorder
Drug: PROVIGIL 200 mg
Drug: Armodafinil 250 mg
Drug: Armodafinil 200 mg
Drug: Armodafinil 150 mg
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Multiple-Dose Plasma Concentration-Time Profiles of Armodafinil (150, 200, and 250 mg) and PROVIGIL® (200 mg) in Patients With Chronic Shift Work Sleep Disorder

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Multiple Sleep Latency Test (MSLT) [ Time Frame: Endpoint (Visit 4) change from baseline (Visit 2) ] [ Designated as safety issue: No ]
    The Multiple Sleep Latency Test (MSLT) is an objective assessment of sleepiness that measures the likelihood of falling asleep. Five 20-minute (maximum) MSLT naps were performed (at 2300, 0100, 0300, 0500, and 0700) at both the screening/baseline assessment visit (Visit 2) and at endpoint (Visit 4). Each nap was terminated after 20 minutes if no sleep occurred. Sleep latency was measured as the elapsed time from lights out to the first epoch scored as sleep.

  • Psychomotor Vigilance Task (PVT) [ Time Frame: Endpoint (Visit 4) change from baseline (Visit 2) ] [ Designated as safety issue: No ]
    The computer-based PVT took 10 minutes to complete and measured reaction time stimulus in milliseconds. The reaction time consisted of the digits 000 initially appearing in a window on the PVT device, after which the 3-digit numbers increased in milliseconds until the response button was pressed by the patient. The resulting number at the button press was the reaction time in milliseconds. There was a variable 1- to 10-second interstimulus interval. After pressing the button in response to each stimulus, the button was released and the patient awaited the next stimulus.


Enrollment: 136
Study Start Date: August 2005
Estimated Study Completion Date: December 2005
Arms Assigned Interventions
Experimental: 1
PROVIGIL 200 mg/day
Drug: PROVIGIL 200 mg
PROVIGIL 200 mg/day
Experimental: 2
Armodafinil 250 mg/day
Drug: Armodafinil 250 mg
Armodafinil 250 mg/day
Experimental: 3
Armodafinil 200 mg/day
Drug: Armodafinil 200 mg
Armodafinil 200 mg/day
Experimental: 4
Armodafinil 150 mg/day
Drug: Armodafinil 150 mg
Armodafinil 150 mg/day
Placebo Comparator: 5
Placebo
Drug: Placebo
Matching placebo tablets

Detailed Description:

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Multiple-Dose Plasma Concentration-Time Profiles of Armodafinil and PROVIGIL in Patients with Chronic Shift Work Sleep Disorder

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients are included in the study if all of the following criteria are met:

  • The patient speaks and writes in English.
  • The patient is a man or woman of any ethnic origin aged 18 through 65 years.
  • The patient is in good health as determined by a medical and psychiatric history, medical examination, serum chemistry, and hematology.
  • The patient has a diagnosis of SWSD according to the International Classification of Sleep Disorders (ICSD) criteria, and must have had excessive sleepiness during night shifts for at least 3 months.
  • The patient must be planning to work at least 3 to 5 nights (per week), of which at least 3 nights will be consecutive.
  • The patient must work night shifts that include at least 6 hours between 2200 and 0800 (+30 minutes) and be no longer than 12 hours (+30 minutes) in duration.
  • The patient has a mean sleep latency of 6 minutes or less as determined by the MSLT (average of naps at 0100, 0300, 0500, and 0700).
  • The patient has a Clinical Global Impression of Severity of Illness (CGI-S) rating of 4 or more as it pertains to sleepiness during night shifts including the commute from work.
  • Women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method 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, and intrauterine device (IUD).
  • The patient is willing to comply with study restrictions and remain at the clinic overnight as required.
  • The patient may have been prescribed PROVIGIL or stimulant therapy for their sleep disorder; however, they must have undergone a washout period of at least 7 days prior to screening assessments done at the second screening visit.

Exclusion Criteria:

Patients are excluded from participating in this study if 1 or more of the following criteria are met:

  • The patient has any clinically significant medical or psychiatric conditions (treated or untreated).
  • The patient has a probable diagnosis of a current sleep disorder other than SWSD.
  • The patient consumes caffeine including coffee, tea, and/or other caffeine-containing beverages or foods averaging more than 600 mg of caffeine/day within 2 weeks of the start of study drug administration.
  • The patient has medically unexplainable positive urine drug screen (UDS) result at the screening visit.
  • The patient has clinically significant deviation from normal in clinical laboratory results, vital signs, or physical examination.
  • The patient has received any investigational drug within 30 days or 5 half-lives (whichever is longer) before study drug administration, or in the case of a new chemical entity, 3 months or 5 half-lives (whichever is longer) before study drug adminstration.
  • The patient used any prescription drugs disallowed by the protocol or clinical significant use of over-the-counter (OTC) drugs within 7 days before the second screening/baseline visit.
  • The patient has any disorder (including gastrointestinal surgery) that may interfere with drug absorption, distribution, metabolism, or excretion.
  • The patient has known or suspected hypersensitivity to stimulants and/or modafinil or any ingredient present in the study drug.
  • The patient has a history (within the past 5 years) of alcohol, narcotic, or any other drug abuse as defined by the Diagnostic and Statistical Manual or Mental Disorders of the American Psychiatric Association, Fourth Edition, Text Revision (DSM-IV-TR).
  • The patient is a pregnant or lactating woman.
  • The patient has donated, within 56 days prior to study drug administration, any blood or plasma in excess of 450 mL.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00236080

Locations
United States, Arizona
Psypharma Clinical Research
Phoenix, Arizona, United States, 85050
PsyPharma Clinical Tucson
Tucson, Arizona, United States, 85712
United States, Arkansas
Central Arkansas Research
Hot Springs, Arkansas, United States, 71913
United States, California
Pacific Sleep Medicine Service
Los Angeles, California, United States, 90048
Pacific Sleep Medicine Service
San Diego, California, United States, 92121
BMR HealthQuest
San Diego, California, United States, 92123
Stanford University
Stanford, California, United States, 94305
United States, Georgia
Neurotrials Research
Atlanta, Georgia, United States, 30342
SLEEPMED, Inc.
Macon, Georgia, United States, 31202
United States, Illinois
Henry Lahmeyer, MD
Northfield, Illinois, United States, 60093
United States, Kansas
Vince and Associates Clinical
Overland Park, Kansas, United States, 66211
United States, Maryland
Center for Sleep/Wake Disorder
Chevy Chase, Maryland, United States, 20815
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Nevada
Clinical Rsch Center of Nevada
Las Vegas, Nevada, United States, 89104
United States, New York
Clinilabs / Sleep Disorders In
New York, New York, United States, 10025
United States, North Carolina
Wake Research Associates
Raleigh, North Carolina, United States, 27612
United States, Ohio
St. Vincent Mercy Medical Cent
Toledo, Ohio, United States, 43608
United States, Pennsylvania
Consolidated Clinical Trials
Pittsburgh, Pennsylvania, United States, 15221
United States, South Carolina
SleepMed of South Carolina
Columbia, South Carolina, United States, 29201
United States, Utah
Radiant Research Salt Lake
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
Cephalon
Investigators
Study Director: Gwendolyn Neibler, DO Cephalon
  More Information

No publications provided

Responsible Party: Sponsor's Medical Expert, Cephalon
ClinicalTrials.gov Identifier: NCT00236080     History of Changes
Other Study ID Numbers: C10953/3045/CM/US
Study First Received: October 7, 2005
Results First Received: June 1, 2009
Last Updated: July 12, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sleep Disorders
Parasomnias
Sleep Disorders, Circadian Rhythm
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Chronobiology Disorders
Dyssomnias
Occupational Diseases
Modafinil
Armodafinil
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014