Clinical trial NCT00228566: Study to Assess Patient Reported Outcomes With Armodafinil Treatment for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Excessive Daytime Sleepiness
Narcolepsy
Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS)
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-29
Enrollment: 247
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Responders to the Patient Global Impression of Change (PGI-C) Ratings
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Sleep Disorders Center of Alabama
state: Alabama
city: Tuscaloosa
country: United States
facility: Neurology Consultants of Tuscaloosa, P.C.
state: Alabama
city: Phoenix
country: United States
facility: Pulmonary Associates
state: Arizona
city: Phoenix
country: United States
facility: HOPE Research Institute
state: Arizona
city: Phoenix
country: United States
facility: PsyPharm Clinical Research
state: Arizona
city: Tucson
country: United States
facility: PsyPharm Clinical Research Inc.
state: Arizona
city: Little Rock
country: United States
facility: Neurology and Clinical Study Center
state: Arkansas
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute
state: California
city: Long Beach
country: United States
facility: West Coast Clinical Trials, Inc
state: California
city: Pasadena
country: United States
facility: Neuro-Therapeutics, Inc
state: California
city: Rolling Hills Estates
country: United States
facility: Penninsula Research Associates
state: California
city: San Francisco
country: United States
facility: Pacific Sleep Program
state: California
city: Santa Barbara
country: United States
facility: The Sleep Disorders Center of Santa Barbara
state: California
city: Englewood
country: United States
facility: Colorado Sleep Disorder Center
state: Colorado
city: St. Petersburg
country: United States
facility: Clinical Research Group of St. Petersburg
state: Florida
city: Atlanta
country: United States
facility: Child Neurology Associates, PC
state: Georgia
city: Atlanta
country: United States
facility: Neurotrials, Inc.
state: Georgia
city: Macon
country: United States
facility: Sleepmed Inc.
state: Georgia
city: Savannah
country: United States
facility: Savannah Neuurology
state: Georgia
city: Evanston
country: United States
facility: Evanston Northwestern Healthcare, Evanston Hospital
state: Illinois
city: Waterloo
country: United States
facility: Convenant Clinic
state: Iowa
city: Louisville
country: United States
facility: Chest Medicine Assocaites d/b/a/ Sleep Medicine Specialists
state: Kentucky
city: Chevy Chase
country: United States
facility: Center for Sleep and Wake Disorders
state: Maryland
city: Newton
country: United States
facility: Neurocare. Inc
state: Massachusetts
city: Fayetteville
country: United States
facility: Cumberland Research Associates
state: North Carolina
city: Akron
country: United States
facility: Neurology and Neuro Science Associates
state: Ohio
city: Beechwood
country: United States
facility: North Coast Clinical Trials, Inc.
state: Ohio
city: Oklahoma City
country: United States
facility: Jonathan Schwartz
state: Oklahoma
city: Portland
country: United States
facility: Pacific Sleep Program
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Upland
country: United States
facility: Crozer Chester Medical Center
state: Pennsylvania
city: West Chester
country: United States
facility: University Services
state: Pennsylvania
city: Columbia
country: United States
facility: SleepMed of South Carolina
state: South Carolina
city: Morristown
country: United States
facility: Healthstar Physicians
state: Tennessee
city: Nashville
country: United States
facility: Sleep Medicine of Tennesse
state: Tennessee
city: Allen
country: United States
facility: Metroplex Pulmonary and Sleep Center, PA
state: Texas
city: Austin
country: United States
facility: FutureSearch Trials
state: Texas
city: Plano
country: United States
facility: Sleep Medicine Associates of Texas, P.A
state: Texas
city: San Antonio
country: United States
facility: Texas Association of Pediatric Neurology
state: Texas
city: Essex Junction
country: United States
facility: Vermont Medical Sleep Disorders Center
state: Vermont
city: Vienna
country: United States
facility: Sleep Disorders Center of the Mid Atlantic
state: Virginia
city: Kirkland
country: United States
facility: Pacific Institute of Medical Science
state: Washington
city: Seattle
country: United States
facility: Pacific Institute of Mental Health
state: Washington
Study officials:
affiliation: Cephalon
name: Sponsor's Medical Expert, MD
role: STUDY_DIRECTOR
References: