Study of the Efficacy and Multiple-Dose Plasma Concentration-Time Profiles of Armodafinil and PROVIGIL
Information source: Cephalon
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Shift Work Sleep Disorder
Intervention: PROVIGIL (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Cephalon Official(s) and/or principal investigator(s):
Gwendolyn Neibler, DO, Study Director, Affiliation: Cephalon
Summary
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
Clinical Details
Official title: 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
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: The purpose of the study is to compare the overnight efficacy and plasmaconcentration-time profiles of armodafinil and PROVIGIL, after multiple doses, in patients with excessive sleepiness associated with chronic SWSD.
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Psypharma Clinical Research, Phoenix, Arizona 85050, United States
PsyPharma Clinical Tucson, Tucson, Arizona 85712, United States
Central Arkansas Research, Hot Springs, Arkansas 71913, United States
Stanford University, Stanford, California 94305, United States
Pacific Sleep Medicine Service, San Diego, California 92121, United States
Pacific Sleep Medicine Service, Los Angeles, California 90048, United States
BMR HealthQuest, San Diego, California 92123, United States
Neurotrials Research, Atlanta, Georgia 30342, United States
SLEEPMED, Inc., Macon, Georgia 31202, United States
Henry Lahmeyer, MD, Northfield, Illinois 60093, United States
Vince and Associates Clinical, Overland Park, Kansas 66211, United States
Center for Sleep/Wake Disorder, Chevy Chase, Maryland 20815, United States
Brigham and Women's Hospital, Boston, Massachusetts 02115, United States
Clinical Rsch Center of Nevada, Las Vegas, Nevada 89104, United States
Clinilabs / Sleep Disorders In, New York, New York 10025, United States
Wake Research Associates, Raleigh, North Carolina 27612, United States
St. Vincent Mercy Medical Cent, Toledo, Ohio 43608, United States
Consolidated Clinical Trials, Pittsburgh, Pennsylvania 15221, United States
SleepMed of South Carolina, Columbia, South Carolina 29201, United States
Radiant Research Salt Lake, Salt Lake City, Utah 84107, United States
Additional Information
Starting date: August 2005
Ending date: December 2005
Last updated: July 3, 2006
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