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

NCT00228566 | Completed Phase 3 Results

• 1 other identifier: C10953/3046/ES/US
• Study Type: interventional
• Target: 247
• Locations: 1 country
• Sites: 43

Brief Summary

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.

Conditions

Excessive Daytime Sleepiness; Narcolepsy; Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS)

Outcome Measures

Primary Outcomes (1)

• Number of Responders to the Patient Global Impression of Change (PGI-C) Ratings

  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until the Final Visit, which occurs when the product is commercially available or the marketing application is withdrawn.

Interventions

Armodafinil DRUG

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cephalon: lead

Study Sites (43)

Sleep Disorders Center of Alabama

Birmingham, Alabama, 35213, United States

Location

Neurology Consultants of Tuscaloosa, P.C.

Tuscaloosa, Alabama, 35406, United States

Location

Pulmonary Associates

Phoenix, Arizona, 85006, United States

Location

HOPE Research Institute

Phoenix, Arizona, 85032, United States

Location

PsyPharm Clinical Research

Phoenix, Arizona, 85050, United States

Location

PsyPharm Clinical Research Inc.

Tucson, Arizona, 85712, United States

Location

Neurology and Clinical Study Center

Little Rock, Arkansas, 72205, United States

Location

Advanced Clinical Research Institute

Anaheim, California, 92801, United States

Location

West Coast Clinical Trials, Inc

Long Beach, California, 90806, United States

Location

Neuro-Therapeutics, Inc

Pasadena, California, 91105, United States

Location

Penninsula Research Associates

Rolling Hills Estates, California, 90274, United States

Location

Pacific Sleep Program

San Francisco, California, 94109, United States

Location

The Sleep Disorders Center of Santa Barbara

Santa Barbara, California, 93103, United States

Location

Colorado Sleep Disorder Center

Englewood, Colorado, 80113, United States

Location

Clinical Research Group of St. Petersburg

St. Petersburg, Florida, 33707, United States

Location

Child Neurology Associates, PC

Atlanta, Georgia, 30342, United States

Location

Neurotrials, Inc.

Atlanta, Georgia, 30342, United States

Location

Sleepmed Inc.

Macon, Georgia, 31201, United States

Location

Savannah Neuurology

Savannah, Georgia, 31405, United States

Location

Evanston Northwestern Healthcare, Evanston Hospital

Evanston, Illinois, 60201, United States

Location

Convenant Clinic

Waterloo, Iowa, 50702, United States

Location

Chest Medicine Assocaites d/b/a/ Sleep Medicine Specialists

Louisville, Kentucky, 40217, United States

Location

Center for Sleep and Wake Disorders

Chevy Chase, Maryland, 20815, United States

Location

Neurocare. Inc

Newton, Massachusetts, 02459, United States

Location

Cumberland Research Associates

Fayetteville, North Carolina, 28304, United States

Location

Neurology and Neuro Science Associates

Akron, Ohio, 44302, United States

Location

North Coast Clinical Trials, Inc.

Beechwood, Ohio, 44122, United States

Location

Jonathan Schwartz

Oklahoma City, Oklahoma, 73109, United States

Location

Pacific Sleep Program

Portland, Oregon, 97209, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Crozer Chester Medical Center

Upland, Pennsylvania, 19013, United States

Location

University Services

West Chester, Pennsylvania, 19380, United States

Location

SleepMed of South Carolina

Columbia, South Carolina, 29201, United States

Location

Healthstar Physicians

Morristown, Tennessee, 37813, United States

Location

Sleep Medicine of Tennesse

Nashville, Tennessee, 37205, United States

Location

Metroplex Pulmonary and Sleep Center, PA

Allen, Texas, 75013, United States

Location

FutureSearch Trials

Austin, Texas, 78756, United States

Location

Sleep Medicine Associates of Texas, P.A

Plano, Texas, 75093, United States

Location

Texas Association of Pediatric Neurology

San Antonio, Texas, 78258, United States

Location

Vermont Medical Sleep Disorders Center

Essex Junction, Vermont, 05452, United States

Location

Sleep Disorders Center of the Mid Atlantic

Vienna, Virginia, 22182, United States

Location

Pacific Institute of Medical Science

Kirkland, Washington, 98034, United States

Location

Pacific Institute of Mental Health

Seattle, Washington, 98133, United States

Location

MeSH Terms

Conditions

Disorders of Excessive Somnolence; Narcolepsy; Sleep Apnea, Obstructive

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

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

1-877-237-4879

Study Officials

• Sponsor's Medical Expert, MD

  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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 27, 2005
• First Posted: September 29, 2005
• Study Start: October 1, 2005
• Study Completion: July 1, 2006
• Last Updated: July 19, 2013
• Results First Posted: June 25, 2010

Record last verified: 2013-07

Locations

US (43)