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

NCT00236080 | Completed Phase 3 Results

• 1 other identifier: C10953/3045/CM/US
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 20

Brief Summary

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).

Conditions

Chronic Shift Work Sleep Disorder

Outcome Measures

Primary Outcomes (2)

• Multiple Sleep Latency Test (MSLT)

  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.

  Endpoint (Visit 4) change from baseline (Visit 2)

• Psychomotor Vigilance Task (PVT)

  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.

  Endpoint (Visit 4) change from baseline (Visit 2)

Study Arms (5)

1

EXPERIMENTAL

PROVIGIL 200 mg/day

Drug: PROVIGIL 200 mg

2

EXPERIMENTAL

Armodafinil 250 mg/day

Drug: Armodafinil 250 mg

3

EXPERIMENTAL

Armodafinil 200 mg/day

Drug: Armodafinil 200 mg

4

EXPERIMENTAL

Armodafinil 150 mg/day

Drug: Armodafinil 150 mg

5

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

PROVIGIL 200 mg DRUG

PROVIGIL 200 mg/day

1

Armodafinil 250 mg DRUG

Armodafinil 250 mg/day

2

Armodafinil 200 mg DRUG

Armodafinil 200 mg/day

3

Armodafinil 150 mg DRUG

Armodafinil 150 mg/day

4

Placebo DRUG

Matching placebo tablets

5

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cephalon: lead

Study Sites (20)

Psypharma Clinical Research

Phoenix, Arizona, 85050, United States

Location

PsyPharma Clinical Tucson

Tucson, Arizona, 85712, United States

Location

Central Arkansas Research

Hot Springs, Arkansas, 71913, United States

Location

Pacific Sleep Medicine Service

Los Angeles, California, 90048, United States

Location

Pacific Sleep Medicine Service

San Diego, California, 92121, United States

Location

BMR HealthQuest

San Diego, California, 92123, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Neurotrials Research

Atlanta, Georgia, 30342, United States

Location

SLEEPMED, Inc.

Macon, Georgia, 31202, United States

Location

Henry Lahmeyer, MD

Northfield, Illinois, 60093, United States

Location

Vince and Associates Clinical

Overland Park, Kansas, 66211, United States

Location

Center for Sleep/Wake Disorder

Chevy Chase, Maryland, 20815, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Clinical Rsch Center of Nevada

Las Vegas, Nevada, 89104, United States

Location

Clinilabs / Sleep Disorders In

New York, New York, 10025, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

St. Vincent Mercy Medical Cent

Toledo, Ohio, 43608, United States

Location

Consolidated Clinical Trials

Pittsburgh, Pennsylvania, 15221, United States

Location

SleepMed of South Carolina

Columbia, South Carolina, 29201, United States

Location

Radiant Research Salt Lake

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Interventions

Modafinil

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

In analyzing the PVT data, it was discovered that data transfer errors had occurred at certain study centers. The ability to interpret the efficacy results from this study is limited, and the findings should be considered inconclusive.

Results Point of Contact

• Title: Sponsor's Medical Director, Clinical Research
• Organization: Cephalon, Inc.

1-877-237-4879

Study Officials

• Gwendolyn Neibler, DO

  Cephalon

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 7, 2005
• First Posted: October 12, 2005
• Study Start: August 1, 2005
• Study Completion: December 1, 2005
• Last Updated: July 19, 2013
• Results First Posted: February 3, 2010

Record last verified: 2013-07

Locations

US (20)