Study to Assess Patient Reported Outcomes With Armodafinil Treatment for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome

July 12, 2013 updated by: Cephalon

A Short-term (8 Week) Open-Label Study, Followed by a Long Term Evaluation, to Assess Patient-Reported Outcomes With Armodafinil Treatment (150 to 250 mg/Day) for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome

The purpose of this study is to assess patient reported outcomes with armodafinil treatment in terms of improvement in sleepiness, satisfaction with treatment, impact on ability to engage in life activities (ie, daily or work and family and/or social activities), and effects on fatigue. Clinician ratings on patient response to armodafinil treatment will also be assessed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: Armodafinil

Study Type

Interventional

Enrollment (Actual)

247

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Alabama
  - Birmingham, Alabama, United States, 35213
    - Sleep Disorders Center of Alabama
  - Tuscaloosa, Alabama, United States, 35406
    - Neurology Consultants of Tuscaloosa, P.C.
- Arizona
  - Phoenix, Arizona, United States, 85006
    - Pulmonary Associates
  - Phoenix, Arizona, United States, 85032
    - Hope Research Institute
  - Phoenix, Arizona, United States, 85050
    - PsyPharm Clinical Research
  - Tucson, Arizona, United States, 85712
    - PsyPharm Clinical Research Inc.
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - Neurology and Clinical Study Center
- California
  - Anaheim, California, United States, 92801
    - Advanced Clinical Research Institute
  - Long Beach, California, United States, 90806
    - West Coast Clinical Trials, Inc
  - Pasadena, California, United States, 91105
    - Neuro-Therapeutics, Inc
  - Rolling Hills Estates, California, United States, 90274
    - Penninsula Research Associates
  - San Francisco, California, United States, 94109
    - Pacific Sleep Program
  - Santa Barbara, California, United States, 93103
    - The Sleep Disorders Center of Santa Barbara
- Colorado
  - Englewood, Colorado, United States, 80113
    - Colorado Sleep Disorder Center
- Florida
  - St. Petersburg, Florida, United States, 33707
    - Clinical Research Group of St. Petersburg
- Georgia
  - Atlanta, Georgia, United States, 30342
    - Child Neurology Associates, PC
  - Atlanta, Georgia, United States, 30342
    - NeuroTrials, Inc.
  - Macon, Georgia, United States, 31201
    - SleepMed Inc.
  - Savannah, Georgia, United States, 31405
    - Savannah Neuurology
- Illinois
  - Evanston, Illinois, United States, 60201
    - Evanston Northwestern Healthcare, Evanston Hospital
- Iowa
  - Waterloo, Iowa, United States, 50702
    - Convenant Clinic
- Kentucky
  - Louisville, Kentucky, United States, 40217
    - Chest Medicine Assocaites d/b/a/ Sleep Medicine Specialists
- Maryland
  - Chevy Chase, Maryland, United States, 20815
    - Center For Sleep and Wake Disorders
- Massachusetts
  - Newton, Massachusetts, United States, 02459
    - Neurocare. Inc
- North Carolina
  - Fayetteville, North Carolina, United States, 28304
    - Cumberland Research Associates
- Ohio
  - Akron, Ohio, United States, 44302
    - Neurology and Neuro Science Associates
  - Beechwood, Ohio, United States, 44122
    - North Coast Clinical Trials, Inc.
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73109
    - Jonathan Schwartz
- Oregon
  - Portland, Oregon, United States, 97209
    - Pacific Sleep Program
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19104
    - University of Pennsylvania
  - Upland, Pennsylvania, United States, 19013
    - Crozer Chester Medical Center
  - West Chester, Pennsylvania, United States, 19380
    - University Services
- South Carolina
  - Columbia, South Carolina, United States, 29201
    - Sleepmed of South Carolina
- Tennessee
  - Morristown, Tennessee, United States, 37813
    - HealthStar Physicians
  - Nashville, Tennessee, United States, 37205
    - Sleep Medicine of Tennesse
- Texas
  - Allen, Texas, United States, 75013
    - Metroplex Pulmonary and Sleep Center, PA
  - Austin, Texas, United States, 78756
    - FutureSearch Trials
  - Plano, Texas, United States, 75093
    - Sleep Medicine Associates of Texas, P.A
  - San Antonio, Texas, United States, 78258
    - Texas Association of Pediatric Neurology
- Vermont
  - Essex Junction, Vermont, United States, 05452
    - Vermont Medical Sleep Disorders Center
- Virginia
  - Vienna, Virginia, United States, 22182
    - Sleep Disorders Center of the Mid Atlantic
- Washington
  - Kirkland, Washington, United States, 98034
    - Pacific institute of medical science
  - Seattle, Washington, United States, 98133
    - Pacific Institute of Mental Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Written informed consent is obtained.
The patient is a man or a woman aged 18 through 65 years of age (inclusive) and English-speaking.
The patient has excessive sleepiness associated with a diagnosis of narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS) according to the International Classification of Sleep Disorders (ICSD) criteria. For OSAHS, the patient must be a regular nasal continuous positive airway pressure (nCPAP) therapy user (usage at least 4 hours/night on at least 70% of nights), must have documented adequate education and intervention efforts to encourage nCPAP therapy use, the patient's nCPAP therapy regimen must be stable for at least 4 weeks prior to study entry, and the patient's nCPAP therapy must be effective in the opinion of the investigator.
The patient is in good health as determined by a medical and psychiatric history, clinical laboratory tests, vital signs measurements, electrocardiography (ECG), physical examination, and urine drug screen (UDS) at screening.
If currently receiving therapy for excessive sleepiness associated with their sleep disorder, the patient is dissatisfied because of efficacy and/or safety with their current therapy (i.e., pharmacologic, nap, or bright light therapy), if taken, for excessive sleepiness associated with their sleep disorder.
The patient has a Clinical Global Impression of Severity of Illness (CGI-S) rating at baseline of 4 or more (i.e., at least moderately ill).
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, or intrauterine device (IUD).
The patient must be willing and able to comply with study procedures and restrictions, including the completion of self-rating scales, and be willing to return to the study center for visits as specified in this protocol.
The patient may have been prescribed pharmacologic therapy for excessive sleepiness associated with a sleep disorder; however, they must have undergone a washout period of at least 7 days prior to the baseline visit.

Exclusion Criteria:

Patients are excluded from participating in this study if any of the following criteria are met:

The patient has any treated or untreated clinically significant uncontrolled medical or psychiatric conditions.
The patient has a probable diagnosis of a current sleep disorder other than the primary diagnosis of narcolepsy, OSAHS, or other etiology for the complaint of excessive sleepiness.
The patient consumes caffeine including coffee, tea and/or other caffeine-containing beverages or food averaging more than 600 mg of caffeine/day within 1 week of the start of study drug administration.
The patient has a medically unexplainable positive UDS at the screening visit.
The patient has a clinically significant deviation from normal in clinical laboratory test results, vital signs values, or physical examination findings observed at the screening visit.
The patient has used an investigational drug within 30 days or 5 half-lives (whichever is longer) before study drug administration.
The patient has used any prescription drugs disallowed by the protocol within 7 days before the baseline visit.
The patient has a known or suspected hypersensitivity to armodafinil or any compound present in the study drug or related compounds.
The patient is pregnant or lactating. (Any patients becoming pregnant during the study will be withdrawn from the study).
The patient has any disorder (including gastrointestinal surgery) that may interfere with drug absorption, distribution, metabolism, or excretion.
The patient has a history of alcohol, narcotic,or any other drug abuse as defined by the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association, 4th Edition (DSM-IV) within the past 5 years.
The patient has a history of repeated therapeutic failure to therapies for excessive sleepiness.
The patient previously participated in a clinical study with armodafinil.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Responders to the Patient Global Impression of Change (PGI-C) Ratings Time Frame: Weeks 4, 8, and 12, at 3 month intervals thereafter, and at a Final Visit (or last postbaseline observation). Evaluation continues until the Final Visit, which occurs when the product is commercially available or the marketing application is withdrawn.	A subjective measure (PGI-C rating) of the patient's global health, ie, a patient's rating of disease severity, as compared with a pretreatment (baseline) evaluation assessment by the patient using the Patient Global Impression of Severity of illness (PGI-S). Responders at each visit were defined as having at least minimal improvement in the severity of excessive sleepiness as compared with a pretreatment evaluation made using the PGI-S.	Weeks 4, 8, and 12, at 3 month intervals thereafter, and at a Final Visit (or last postbaseline observation). Evaluation continues until the Final Visit, which occurs when the product is commercially available or the marketing application is withdrawn.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cephalon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Study Completion (ACTUAL)

July 1, 2006

Study Registration Dates

First Submitted

September 27, 2005

First Submitted That Met QC Criteria