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

Narcolepsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00228566
• Other study ID #: C10953/3046/ES/US
• Status: Completed
• Phase: Phase 3
• First received: September 27, 2005
• Last updated: July 12, 2013
• Start date: October 2005
• Est. completion date: July 2006

Study information

• Verified date: July 2013
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 247
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Disorders of Excessive Somnolence
• Excessive Daytime Sleepiness
• Narcolepsy
• Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS)
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

Drug:
• Armodafinil

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Cephalon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No